Category Archives: Cf

Verona Pharmarecentlyannounced the companys accomplishments in the last six months, including an update to the companys clinical trial in cystic fibrosis (CF) and positive interim results for its investigational therapy RPL554.

RPL554 is an inhaled dual inhibitor of two enzymes, phosphodiesterase 3 and 4, and was previously shown to significantly improve lung function when compared to placebo treatment. RPL554 acts as an effective bronchodilator and haspotent anti-inflammatory properties.

Verona is conducting aPhase 2a trial (NCT02919995) evaluating RPL554 in up to 10 patients with CF in the U.K. The study will evaluate the effects of escalating doses of the drugversus placebo in adult CF patients to determine the therapys tolerability, pharmacokinetics (its movement within the body from absorption to distribution, metabolism, and excretion), and pharmacodynamics (its effects and mechanism of action). The effects ofRPL554 on lung function also will be assessed.

The study includes three groups: a high-dose group in whichpatients will receive a single inhaled dose of 6 mg of RPL554; a low-dose group with a single inhaled dose of 1.5 mgof RPL554; and a placebo control group. All three will be administered via a nebulizer.

The study is currently recruiting participants. Results fromthis trial are expected to be available in thefirst half of 2018.

In addition to CF,Verona Pharma also is developing RPL554 for the treatment of chronic obstructive pulmonary disease (COPD) and possibly asthma.

It has been a transformative six months forVerona Pharma, Jan-Anders Karlsson, CEO ofVerona Pharma, said in apress release.We now have the team and funding to deliver a comprehensive package of Phase 2b data for nebulized RPL554 as maintenance therapy for both COPD and CF, as well as for the treatment of acute exacerbations of COPD.

Karlsson said the company looks forward to updating the market on multiple clinical data points in this and coming years.

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CF Patients in Europe Wanted for Phase 2 Trial of Investigational Therapy RPL554 - Cystic Fibrosis News Today

Kate Farms, which specializes in plant-based, ready-to-use oral and tube feeding formulas, has rolled out itsCore Essentials Peptide 1.5 product. The high-caloric, peptide-based formula contains no dairy, soy, gluten, or other common allergens.

With its approval by the Healthcare Common Procedure Coding System (HCPCS), it is now possible for patients across the U.S. to have the Core Essentials Peptide 1.5 formula covered by Medicare, Medicaid, and private health insurance programs.

According to Kate Farms, about 437,000 people in the U.S. are getting their nutrition primarily through a tube on a long-term basis. Conditions that may lead to weight loss and the inability to assimilate nutrition orally include cystic fibrosis (CF), cerebral palsy, ALS, multiple sclerosis, and many types of cancer.

The Feeding Tube Awareness Foundation, a nonprofitcharity dedicated to supporting parents of children who are being tube-fed and promoting tube feeding as a lifesaving medical intervention, has identified more than 300 conditions that can require children to need nutritional support through tube feeding.

Before Kate Farms launched its Core Essentials Peptide 1.5 nationally, it supplied physicians and registered dietitians with samples of the new product for their patients to try. As a result, many patients have transitioned to the Peptide formula as a better nutritional alternative to what they had been using, according to Kate Farms. The company will also provide free samples to individuals with a prescribed need for liquid nutrition at the request of a licensed health care professional. Sample program terms and conditions can be found here.

I have had the opportunity to provide Kate Farms Core Essentials Peptide to my patients, and they are showing great improvement in their health, their weight gain, and how much they enjoy it, Dr. Annette Whitney, a pediatric gastroenterologist with Digestive Health Associates of Texas, said in a Kate Farms press release.I am thrilled that the product is now covered by insurance, making it accessible to so many more patients, said Whitney, whose practice isaffiliated with Medical City Childrens Hospital and Childrens Health.

Kate Farms Core Essentials Peptide 1.5 is designed to promote healing of the gastrointestinal tract. It contains a variety of natural and easily digestible ingredients to supply caloric density.

Each 325 mL carton serving of Core Essentials Peptide 1.5 provides: 500 calories, or 1.5 cal / mL; 24 grams of organic hydrolyzed pea protein and essential amino acids; MCT oil from coconut, and omega 3 and omega 6 from organic flax seed oil.

Like other Kate Farms Core Essentials formulas, the Peptide formula is: Free of the top allergens (no milk, wheat, soybeans, eggs, peanuts, tree nuts, fish, shellfish) and corn; Made with organic ingredients; Non-GMO Project Verified; Includes a blend of 29 superfoods that provide antioxidants; Certified gluten-free by The National Celiac Association; Certified OU Kosher; Covered by insurance.

The formula also contains the probiotic agave inulin, has no high-fructose corn syrup, and flows smoothly through the tube.

Full nutritional and ingredients details can be downloaded here.

For enteral patients, it makes a world of difference when Im able to offer formulas that provide healthy sources of nutrition that are easily digestible but that can often be hard to find, said Zachari Breeding, clinical nutrition manager at Kate Farms. As a dietitian, Im excited to now be able to order nutritional formulas that are covered by insurance.

The story behind Kate Farms is about Richard and Michelle Lavers daughter Kate, who was born with cerebral palsy and weighed only 16 pounds when she was 4 years old. Doctors said she was failing to thrive.

Kate has had four Kate Farms shakes a day for years and she is now thriving and able to go to school to live her best life, Brett Matthews, chairman and CEO of Kate Farms, said in the release. We are inspired by Kate and also the stories we hear each day from tube-feeders, caregivers, medical professionals and all who are using Kate Farms as a cornerstone to their overall health and well-being.

We believe in the power of nutrition to heal and are excited to offer Kate Farms Core Essentials as a choice for tube feeders across the nation, Matthews said.

For more information, visithttps://katefarms.com.

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Kate Farms Launches Core Essentials Peptide Tube Feeding Formula for CF, Other Conditions - Cystic Fibrosis News Today

MARION Three players shot 77 or under, and the Cedar Falls boys golf team opened its season with a second-place finish at the 13-team Linn-Mar Invitational Monday.

The Tigers finished with a team score of 314, just two strokes behind victorious Cedar Rapids Kennedy.

Joe Dean and Trevor Heinen paced the Tigers by each shooting a 76, while Ben Bermel was right behind with 77. Jack Moody and Kevin Yang each shot 85 to round out the scoring.

Individually, Jake Marvelli of Indianola and Drew Brandel of Linn-Mar tied for the top score with a 74.

TEAM SCORES: 1. C.R. Kennedy 312, 2. Cedar Falls 314, 3. Indianola 316, 4. Waukee 318, 5. C.R. Washington 322, 6 (tie). C.R. Xavier and Linn-Mar 325, 8. Dowling Catholic 326, 9. Prairie 329, 10. Dubuque Senior 334, 11. Western Dubuque 349, 12. Iowa City High 355, 13. C.R. Jefferson 405.

CEDAR FALLS SCORERS: Joe Dean and Trevor Heinen 76, Ben Bermel 77, Jack Moody and Kevin Yang 85.

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Prep golf: CF Boys take second at Linn-Mar - Waterloo Cedar Falls Courier

The aluminium Inflite has been Canyons sole cyclocross offering for some years and also serves as an all-season road training machine. For a company known for its comprehensive model line up, the lack of a truly competitive crosser was a gap that needed filling. Enter the Inflite CF SLX, which in Canyon speak is carbon fibre, and is already a Red Dot Design Award winner for 2017.

Any thoughts that Canyon might simply recreate the aluminium Inflite in carbon were thankfully immediately dashed on seeing the new bike. From the outset, Canyons sole intention was to focus on the specific demands of cyclocross racing and find ways of satisfying them. The new bike is designed for racing, with no secondary use compromises there are no fender mounts here.

The engineers considered the nature of modern cyclocross races, with higher speeds, greater technical challenges, physical obstacles, the variety of terrain and conditions, and the skill level of current racers the best of whom specialise in the sports unique demands. They concluded that the new Inflite needed to be agile, easy to lift and carry, as light, stiff and durable as possible, and have good clearances, all while maintaining some comfort.

To satisfy two divergent needs, Canyon created the striking raised, kinked top tube. Rather than a sloping top tube, this higher, horizontal design increases the space inside the main triangle for easier shouldering, and drops away towards the seat stays to maximise the length of exposed seatpost for greater seated comfort and traction.

Just ahead of that kink is the bikes natural balance point and exactly the place to pick it up for obstacles requiring a dismount and bike carry on one side. Its a pretty good place to put your shoulder too, and Canyon has patented its carrying concept.

The down tube angle is 1.5 degrees steeper to increase the gap between it and the front tyre. For those who wrap their arm around the down tube and grab the end of the bar when shouldering the bike, this is a good thing.

Crucially for a pure race bike, the frame is completely UCI-legal and Canyon claims that a medium example weighs 940g for frame only and under 1,300g as a frameset.

Canyon used its own in-house CT scanner to examine the frame stresses that are unique to CX, especially dismounts, remounts and jumps or bunny hops. Reducing weight required a combination of high tensile and high and intermediate modulus carbon fibre to be used throughout the frameset, but without compromising either its necessary stiffness or durability to withstand these stresses.

Having enough clearance to reduce mud and debris build up is always a challenge in cyclocross, especially for those not fortunate enough to have more than one bike. Canyons solution is to reduce the frames surface area by 8.5 percent in key positions, particularly the slim seatstays and angular chainstays that should shed mud.

Both are bridgeless and widely spaced, also allowing for up to 40mm tyres to be used, and with UCI maximum 33mm tyres fitted, theres 9mm clearance on each side. The down tubes leading edge is substantially slimmed too to reduce muck collection.

Integrating the seatpost clamp beneath and in front of the top tube junction keeps it away from rear wheel spray and allows all of the extended seatpost to deflect, reducing muscle fatigue. Canyon says its 15g lighter than a conventional design and offers up to 15 percent more deflection from as much as 110mm of additional exposed seatpost.

There are 1x and 2x drivetrain options, with the front mech mounting bolts housing a Canyon-designed 13g plastic chain catcher for single ring setups. All cable routing is internal, whether 1x, 2x or electronic, and potential friction is reduced by fully sealing all frame entry points, including a new splashguard for the front mechs re-sited cable exit. The headset is better sealed too and theres an integrated chain suck plate.

All bikes have 12mm thru-axles and optimised disc rotor sizes in combinations of 140mm and 160mm, depending on frame size and anticipated rider mass. All wheels will be tubeless ready with tubeless valves supplied for each bike, and fitted with Schwalbes tubeless X-One tyres.

Every bike comes with Canyons integrated H31 Ergocockpit CF, which has been tweaked for cross, being 10mm shorter and with wider usable flat tops. The one-piece carbon cockpit is lighter than an individual bar and stem and has less places for dirt to collect, and Canyon says it offers 10 percent more vertical compliance.

The drops are flared by three degrees, the tops are swept back by 6 degrees, they have shorter reach, a greater taping area and a wider, more supportive surface at first bend transition. The H31 will come in five sizes for the eight Inflite frame sizes.

Canyon drew inspiration from mountain biking for the Inflites progressive cross racing geometry and created the broadest size range possible to cater for all riders.

Because courses are faster and more technical, handling accuracy was a priority, so the Inflite has extended reach, longer wheelbase and greater fork rake for stability at speed.

Eight frame sizes start from a new 3XS size for riders from 152cm tall up to 2XL. Both the 3XS and 2XS frames are designed around 650B wheels, which better suit the smaller bikes, reducing trail from 87.3mm to 72.6mm and the head angle from 69- to 70.2-degree compared to a 700c equivalent. It shortens the wheelbase while steepening the head angle and reducing trail, giving the same handling feel as the 700c machines.

Canyon decided to host the Inflite CF SLX launch at the crucible of cross, Zonhoven in Belgium. It seemed surprisingly calm and peaceful compared to my last visit on race day, but the infamous sandy bowl, or De Kuil which translates rather underwhelmingly as The Ditch still looked daunting.

The race was to be three laps of the circuit, including De Kuils longest sandy descent

First up came some dismount and remount tuition from Michael Rich, for those less familiar with the sports technical aspects. Yes, Michael Rich, German 100km team time trial gold medallist at the Olympics in Barcelona in 1992! It turns out hed raced cyclocross before becoming a professional time trial specialist. Then, after a few circuits of a fully taped but truncated Superprestige course, we raced

This is the sort of thinking we like here at BikeRadar! Of course I could get a feel for the new Inflite CF SLX while riding around alone, but a mass start race against 14 others would be a sure fire way to find the bikes and my own, limits.

So far, Id been very pleasantly surprised by the new Inflites performance. I want my cross bike to be reassuringly stable but agile, with great tyre clearance, reasonably low weight and have good bump-smoothing ability to help with control and traction, and the Inflite had delivered on all counts. But would the story be the same when pushed much harder?

We lined up to race in early evening with rain in the air, giving a fitting autumnal feel. The race was to be three laps of the circuit, including De Kuils longest sandy descent and a run up on the other side. Its fair to say that sand was most definitely a feature.

I took the hole shot, which was a surprise, and led through the first soft sand and in to the drag up to De Kuil. A younger, faster and lighter rider passed me before the descent, and when my front wheel washed out in the very deep, steep sand, so did a few more. On the plus side, my first unplanned dismount was followed by the need to carry the bike for the last of the downhill, then remount and sprint across the bottom of the bowl before hopping off, shouldering the Inflite and running the unrideable sandy bank out again.

I couldnt even begin to guess how many times Ive hurriedly shouldered a cross bike and hit my elbow on the down tube because the frame triangle had limited space. That wasnt a problem with the Inflite, and hoisting it by the down tube is often easier and safer still.

Im 178cm/510 and was riding a medium sized Inflite, which was ideal, and weighed in at 7.61kg. Personally I carry the bike on my right shoulder with my arm wrapped around the head tube, holding on to the left brake hood. With the Inflite, my shoulder naturally settled several inches in front of the top tube kink.

Carrying it the alternate way, with my right arm passing below the down tube and gripping the left side drop, gave a similar result. Both felt equally solid and stable, and the elevated top tube allows plenty of room for many individual variations.

Another advantage of the top tubes extra height comes when dismounting and remounting. If arriving at an obstacle to dismount at speed, its good practice to place one hand on the top tube after swinging one leg over, ready to unclip, lift and run. A higher top tube helps confidence when doing this since you dont need to bend to reach it.

Also, when placing the bike back on the ground following a running or shoulder carry, you have a little less distance to lower it, and can remain more upright while doing so.

Schwalbes X-One All Round tyres, set up tubeless in this instance, are tenacious grippers in mixed terrain, and give a good account in light mud too. The sand, gravel and dirt I encountered wasnt much of a challenge, especially with 30mm wide Reynolds Assault LE rims maximising the traction available.

SRAMs 1x systems are simply the best option for cyclocross, and Canyons gearing choice is ideal, with a 40t ring matched with an 11-36 cassette. Yes its heavier and a little more widely spaced than an 11-28, but if you can live with some extra grams, youll likely find it useful.

The woodland singletrack was dispensed easily, then a stony, sandy slope and hairpin before a climb up to another deep sandy descent. I found I could stay settled on the Selle Italia SLR saddle and carry speed through sketchy corners with instant confidence and get back on the gas early on the exit.

Another long running carry was followed by a fast drop down across the heathland trails in to a sharp bend, testing braking control and accuracy, again simply dispatched, before the final quick trails and sandy patches to the finish.

Over the next two laps I felt completely at home on the Inflite, never cursing gappy gearing, just despairing of my fairly poor ability to descend quickly in super soft, steep sand, as it cost me too much time. With light rain falling and light levels dropping, the lungs were burning and the temples throbbing with the maximal efforts, but still the Inflite held every line and got me out of trouble more than once, when things became overly ambitious.

After being passed with half a lap to go by a rider who stretched the limits of the course somewhat, the race was on to the finish. A strong run, fast remount and gung-ho descent saw us exiting the final corner side by side. Different lines and differing sprinting styles saw me just pip him by half a wheel for 4th. I can certainly vouch for the Inflites ability to transmit seated power!

So what did that race prove? It left me certain in the knowledge that Id very happily race the new Inflite CF SLX as its the complete package, ready to race out of the box and it will come boxed.

When thinking what Id look to upgrade, I think the coming season will see many more riders racing tubeless tyres due to their versatility, convenience and lower cost, and the Reynolds Assault LE wheelset is just excellent, so they would stay.

Its a bold decision to supply the full carbon H31 integrated cockpit with every bike, but Canyon is confident its impact testing ensures its easily up to the task of crosss rough and tumble certainly just as much as the competition is.

I found the widened, swept back, flat tops very supportive and grippy for pulling on the bar. I ride in the drops a lot of the time for cross and found them well shaped, with easy reach to the levers. My only personal issue was hitting my wrist on the small radius curve above the levers when descending over bumps at times. Its not hard to account for it when riding, but Id prefer a bit more clearance here.

The overriding impressions were of how good the Inflite CF SLX dealt with the terrain, as I didnt expect such impressive bump smoothing and vibration absorption. Clearly that extra seatpost extension helps at the rear and the fork and handlebar do a good job up front.

Given that tyre pressures were no lower than 25psi/1.7bar, and Im a solid 76kg, theres more potential benefit to be had for some riders. This ride quality really lifts confidence, as I found the following day when tearing along endless twisty, technical singletrack through the trees.

Pushing ever harder in to loose, pine cone covered corners, often with tight gaps on exit, became a challenge the Inflite rose to. Sprinting up or descending soft, steep banks was childs play, with the bike feeling utterly solid, even at that point where youve almost stalled, but just manage to claw your way up and over the lip.

Its impossible not to find yourself descending faster, cornering faster, and clearing sections you might previously have faltered in. The fact that Canyon has made such a wide range of sizes means that a proper race bike is available for just about anyone.

After several hours hammering the Inflite around Zonhoven, my only unanswered question is how well the bike will cope in some truly filthy British mud this winter, but after verifying all of Canyons claims up to now, I doubt it will disappoint.

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Canyon Inflite CF SLX first ride review - BikeRadar - BikeRadar.com

Kinked top tube, integrated cockpit and 650b wheels on smaller sizes on Canyons carbon cyclocross race machine

For the new Canyon Inflite CF SLX carbon cyclocross race bike, launched today, Canyon has developed new solutions to some of the most basic needs of cross racers.

Making the bike easy to carry is a fundamental requirement for cyclocross. Its particularly important for smaller frame sizes, where shouldering space can be limited with a sloping top tube design. Thats why many cyclocross bikes come with horizontal top tubes.

Inflite CF SLXs kinked top tube makes for easy shouldering while adding free seatpost length

But a longer seatpost improves ride quality and handling over bumpy terrain, allowing you to race faster. To add shoulder room while increasing the free length of the seatpost by up to 110mm, Canyon has designed a bend in the top tube. The Inflite CF SLX was developed for racing and its kinked top tube design is UCI legal.

The seatpost is secured by a wedge under the front side of the top tube junction, so adding around 15% extra flex and reducing weight over a conventional seatpost clamp. This patented design lets Canyon keep the top tube horizontal for a gain in shoulder room of up to 37mm over a sloping tube design. Its already received a 2017 RedDot award.

Seatpost is clamped from the underside of the frame theres a rubber bung to stop muck ingress

There is also plenty of wheel clearance: with 33mm tyres, theres more than 9mm clearance and you could easily fit tyres up to 40mm. There are also mud shedding features like a sloping top edge to the drive side chainstay.

>>> Cycling Weekly Adventure Cross series

Cable runs are fully enclosed and their entry and exit points are sealed, as is the seatpost/seat tube junction and the seatpost clamp. Wheels run on 12mm thru-axles with removable levers and there are two sets of bottle bosses. The headset bearings are an untapered 1 inch top and bottom for added steerer rigidity.

Non-tapered 1 inch headset bearings add rigidity

The Inflite CF SLX has a claimed frame weight of 940g and a complete frameset weight of under 1300g for a size M. Canyon says its used its in-house CT scanner to ensure that frame wall thickness is optimised and to examine the results of its stress tests, which have included simulated jumps and remounts.

>>> Six best cyclocross bikes for 2017: a buyers guide

The Inflite CF SLX comes with Canyons new H31 Ergocockpit CF. A single piece carbon fibre bar and stem, Canyon says that this adds stiffness, is lighter than a conventional bar-stem set-up and is also more compliant.

Single piece bar-stem comes with a short reach and backward curved aero bar tops

The bars also have a shorter stem length and are wider than a conventional set-up. Borrowed from mountain bikes, this geometry leads to sharper, more accurate handling. Its a trend were seeing on gravel bikes too.

Equivalent stem lengths on the Inflite are frame size specific and range from 70mm up to 110mm, while bar width increases with frame size from 400mm up to 460mm.

Theres a six degree backward sweep to the bar tops and an ovalised aero section which helps distribute hand pressure. This also shortens the bar reach. Theres a three degree flare to the drops for better control and comfort.

Theres plenty of tyre clearance note the pointed chainstay top to reduce mud build-up

Canyon has designed the Inflite CF SLX to be compatible with both single and two ring options, and offers bikes with both in the range. Its single ring bikes come with a 13g chain catcher mounted in place of the front mech.

The single ring bikes come with Quarq Prime chainsets. These allow you to fit a Quarq DZero power meter, without needing to change the cranks.

Canyon offers the Inflite CF SLX in eight sizes, from 3XS with a top tube length of 501mm up to 2XL with a 617mm top tube. Rather than try to fit 700c wheels into its smaller sizes, the 3XS and 2XS come with 650b wheels. Canyon fits 650b wheels on smaller sizes in its new womens road bike range too.

3XS and 2XS frame sizes come with 650b wheels

650b wheels allow Canyon to keep the frame geometry and trail short for sharp handling, without toe overlap becoming a problem. Chainstay length is decreased to 415mm from the 425mm on 700c variants. Canyon says its smallest frame will fit riders of 152cm in height.

>>> 15 year old tyres used to win Cyclocross World Championship

Canyon also specs shorter stems and narrower bars on its smaller sizes, with five different bar sizes across the size range. And whereas the smallest frames have 140mm brake rotors front and rear, larger bikes switch to 160 front and 140 rear, with the XL and 2XL bikes getting two 160mm rotors. In addition crank length increases from 165mm up to 175mm as frame size increases.

Canyons new cross bikes will be offered in three specification levels.

First up is the 2499 ($2749, EUR2799) Inflite CF SLX 8.0 Pro Race. This comes with a SRAM Rival 1 groupset with 40, 11-36 ratios, a Quarq Prime chainset and a mid cage mech. You get DT Swiss CR1600 Spline DB tubeless ready alloy clinchers with Schwalbe X-One 33mm tyres. The Canyon carbon Ergocockpit is included and theres a Selle Italia SLS saddle on Canyons 27.2mm carbon seatpost. Claimed weight is 8.1kg.

Canyon fits Quarq single ring chainsets on two models, to which you can fit a DZero power meter

The mid-range Inflite CF SLX 9.0 comes with a Shimano Ultegra drivetrain with a Rotor 3D30 chainset. Gear ratio are 46/36, 11-30. Again, the wheels are DT Swiss CR1600 Spline DB with Schwalbe X-One tyres, while the saddle gets an upgrade to a Selle Italia SLR Lite. Claimed weight is 7.9kg and price is 2899 ($3149, EUR 3199).

Top of the tree is the 3599 ($3899, EUR 3999) Inflite CF SLX 9.0 Pro race. With a claimed weight of 7.6kg, this comes with SRAM Force 1 and a Quarq Prime Carbon chainset with 40, 11-36 ratios. Wheels are carbon Reynolds Assault LE Disc and the saddle is a Selle Italia SLR Lite.

You can also buy an Inflite CF SLX frameset for 1799 ($1949, EUR 1999).

We rode the Inflite CF SLX through the sandy woods around Zonhoven in Belgium, scene of the Superprestige cyclocross race coming up on October 15. Heres Canyons launch video shot in the area, including its famous De Kuil sandpit.

Its a bike that feels very nimble over and around obstacles. Its light weight helps with shouldering and means that the bike accelerates well.

>>> Guide to racing cyclocross

I liked the Ergocockpit, the wide tops and flared bars helping with handling and hand pressure distribution when riding over roots and uneven ground. The backward sweep made for a comfortable hand position too.

Inflite CF SLX handles tricky course features well

Were fans of SRAM 1 groupsets for cyclocross here at Cycling Weekly and Canyons set-up and ratio choice worked well, although the chain catcher is prone to rub if you start to collect mud or sand during a race.

>>> Icons of cycling: Three Peaks Cyclocross

All-in-all the Inflite CF SLX is an impressive new entrant to the cyclocross world, with an innovative design, competitive spec and top flight racing credentials thats up with the best crossers weve ridden.

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New Canyon Inflite CF SLX revisits the cyclocross bike ... - Cycling Weekly

Thinly traded nano cap Anthera Pharmaceuticals (NASDAQ:ANTH) is up9%premarket on increased volume in response to its announcement that its Phase 3 RESULT study assessing Sollpura (liprotamase) for exocrine pancreatic insufficiency due to cystic fibrosis has been approved by the European Cystic Fibrosis Society Clinical Trial Network Executive Committee, a decision that should expedite patient recruitment.

Top-line are expected as early as year-end.

Sollpurais a non-porcine pancreatic enzyme replacement therapy (PERT) containing a proprietary engineered cross-linked formulation of crystalline lipase, crystalline protease and amorphous amylase. The company says its solubility and stability offers a more patient-friendly alternative for those who cannot swallow multiple pills or require gastric tubes in order to maintain their nutritional health.

Previously: Anthera's Sollpura on par with Pancreaze in extension phase of late-stage study in certain CF patients; shares ahead 9% after hours (March 29)

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Anthera's late-stage study of Sollpura to be included in European CF network; shares ahead 9% premarket - Seeking Alpha

Another motive To buy these stock: CF Industries Holdings, Inc. (CF), Hologic, Inc. (HOLX) StockNewsJournal CF Industries Holdings, Inc. (NYSE:CF) market capitalization at present is $7.17B at the rate of $30.51 a share. The firm's price-to-sales ratio was noted 1.92 in contrast with an overall industry average of 3.68. Most of the active traders and ... and more »

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Another motive To buy these stock: CF Industries Holdings, Inc. (CF), Hologic, Inc. (HOLX) - StockNewsJournal

Introduction - Rationale for the article

One of the several smaller but commercial-sized biotechs that has been around for decades but is yet to truly emerge as a profitable enterprise, Vertex Pharmaceuticals (NASDAQ:VRTX), is a $37 billion market cap stock. It was one of the early rational drug design companies. With 96% of the shares held by institutions, the public is apparently little involved in trading the stock. However, there are close to 20,000 Seeking Alpha members who have VRTX on a watch list, and certainly many others who follow it, at least from time to time, consistent with the sophistication of Seeking Alpha members.

One of the problems following VRTX is that the terminology used for the disease it specializes in developing drugs for - cystic fibrosis, or CF - is complicated to the point of being inscrutable without special training.

It is hoped that this brief piece may organize and clarify certain technical matters about CF as well as regarding the large and somewhat confusing pipeline that VRTX has amassed. Links to helpful documents and slides are provided that, it is hoped, will be accessible to a general readership.

Introduction to CF

This is a genetic disease. Almost always, neither parent will have CF and will instead be of average health. Thus, CF is a sporadic, seemingly random disease. Per the NIH, the disease occurs in 1 in 2,500 to 3,500 white newborns. Cystic fibrosis is less common in other ethnic groups, affecting about 1 in 17,000 African Americans and 1 in 31,000 Asian Americans.

The clinical hallmarks are most notable in lung function and susceptibility to lower respiratory tract infections and gastrointestinal problems. Cases of CF range from severe to (rarely) mild; some cases are pulmonary-predominant and others have GI-pancreas symptoms more prominent. The simple, accurate test for CF is to measure the amount of an ion, chloride, in the person's sweat. If this is elevated above a certain level and appropriate symptoms exist, CF is generally present. This is the "sweat test" or "chloride sweat test" that you may see if you get into the VRTX and CF literature.

Patients with CF produce abnormally thick fluid in the lungs. Normally, thin mucus or fluid is produced deep in the lungs and swept upward toward the throat, thus clearing germs and particles away from the deepest parts of the lungs. With CF, the mucus or airway fluid is too thick; this is believed to be a key reason for the susceptibility to lung infections, both pneumonia and bronchitis in this disease. Pulmonary problems as well as nutritional insufficiency lead to a diminished quality of life and typically a much shortened life span, especially before the quality of treatment improved in recent decades.

When VRTX tests a drug to ameliorate CF, it measures how much air a CF patient can exhale in one second. This is the FEV1 test, which stands for forced expiratory volume in 1 second. Sometimes this is written as ppFEV1. The higher the FEV1, the better the response to the drug.

Among the secondary endpoints other than additional pulmonary metrics are both general quality of life and weight gain, which is usually desirable in CF patients given their digestive problems.

Some technical details about CF

The specific defect causing CF arises when both parents transmit a mutant CF gene (or allele) to their child; this gene is located on chromosome 7. This mutation leads to inadequate numbers and/or inadequate function of a protein called CFTR (see below for details on CFTR, which is a term used both for the CF gene and for the protein itself).

There are numerous different types of mutations found in CF. Each mutation has a name, which VRTX tends to include in its regulatory filing and press releases, but the specific names do not need attention from investors. What matters most is how many new cases are now eligible for treatment with a VRTX drug.

As an example, on slide 4 of the PowerPoint presentation accompanying the Q2 earnings release, VRTX refers to F508del, a common mutation in CF. This is also called F508 delta. A difficult and common form of CF to treat is one where each parent contributes the same allele, each the F508del mutation. In this case, the CF patient is designated as having the F508del/F508del type. This designation is shown in both the first and the second boxes in that diagram as an important treatment class.

An even more difficult CF type for drug treatment is one where one allele is F508del and the other causes minimal function of the malfunctioning protein. This is called F508del/min. There are also different CFTR types of malfunction which are called "residual function" defects, and VRTX calls the appropriate ones residual function/F508del (or related terms).

These classifications are especially useful to investors in thinking about the market opportunity for VRTX in CF and in assessing its pipeline.

Perhaps the most important point is that if one is studying VRTX, having an understanding of what the company is talking about can demystify the situation enough to allow a focus on the profit opportunity down the road.

Details on CFTR (more technical)

VRTX's marketed and major pipeline drugs have the -caftor suffix unless they are not yet listed by name. This naming is done because the protein that is lacking and/or defective in CF is the cystic fibrosis transmembrance conductance regulator. So, C F T R made into a chemical suffix was turned into caftor.

The CFTR gene contains the code for the CFTR protein. Defects within the spectrum of CF include the CFTR protein:

The CFTR protein plays an important role in regulating fluid balance emanating from epithelial cells. In CF, basically what ends up happening is that sodium is reabsorbed excessively, and sodium carries water with it. This leads to inadequate water content in mucus, thickening it and causing various sorts of damage to pancreatic and other ducts, digestion in the GI tract, and issues with the lungs (and other functions). At the same time, chloride is not reabsorbed properly, leading to high chloride levels in sweat that is a convenient marker of CF.

Because this defect affects epithelial cells in general, CF is a multi-systemic disease.

Introduction to VRTX's marketed drug products for CF: Royalties

Years ago, the company licensed promising caftors from the Cystic Fibrosis Foundation. I seem to remember a 10% royalty rate on drugs that made it to the market, but this is what VRTX says about the arrangement as it exists now in its Q2 10-Q (p. 11):

The Company has a research, development and commercialization agreement with Cystic Fibrosis Foundation Therapeutics Incorporated ("CFFT") that was originally entered into in May 2004, and was most recently amended in October 2016 (the "2016 Amendment"). Pursuant to the agreement, as amended, the Company has agreed to pay royalties ranging from low-single digits to mid-single digits on potential sales of certain compounds first synthesized and/or tested between March 1, 2014 and August 31, 2016 and tiered royalties ranging from single digits to sub-teens on any approved drugs first synthesized and/or tested during a research term on or before February 28, 2014, including (i) KALYDECO (ivacaftor) and ORKAMBI (lumacaftor in combination with ivacaftor), which are the Companys current products and (ii) tezacaftor in combination with ivacaftor. For combination products, such as ORKAMBI, sales will be allocated equally to each of the active pharmaceutical ingredients in the combination product.

Since VRTX plans to more or less replace Orkambi with a tezacaftor/ivacaftor ("T/I") product and use T/I as the backbone of 3-drug combos for the most difficult cases to treat, it's important to note that the royalty rate stays the same for T/I as for the two marketed drugs at this time: Kalydeco and Orkambi. It would appear, though, to me, that the candidates for the third drug may be headed for about 4-5% royalties. If so, then perhaps the royalty rate on these drugs would be around 8%. Depending on the mix of drugs sold, royalties to CFFT, which the company includes in cost of drugs sold, would shrink just a bit as a percentage of revenues if one or more 3-drug combos reached the market - which is, I believe, required for VRTX to end up being a rewarding investment.

Why VRTX may do better with T/I than Orkambi

While Kalydeco demonstrated robust gains in FEV1 and other parameters, it only treats a small percentage of the estimated 75,000 patients with CF in the higher-frequency parts of the world. Orkambi, on the other hand, generated just good enough data to get approval but was less effective than Kalydeco. Then, it has some unwanted side effects, including shortness of breath in some patients. Between limited efficacy and a side effects profile that is not ideal, Orkambi has been a tougher sell than Kalydeco, especially ex-US.

To the rescue is T/I, which VRTX reports had good efficacy in Phase 3 (no direct comparison to Orkambi), though not superb, but a better side effects profile. Marketing applications have been submitted in the US and EU, so I expect marketing to begin in the first half of next year in the US and later in the EU.

The T/I combo is critical to the bulk of VRTX's growth plans.

The promising data on triple therapy

For the toughest cases, and (I speculate) possibly for some cases where T/I may be indicated but may not work too well, three-drug combos may represent a further breakthrough in therapy. VRTX has reported promising results on three different novel agents used in combination with T/I. It has discussed these in press releases and on the conference call, as well as in its 10-Q (pp. 35-38).

What was so well received by the Street in this heavily institutional stock is that unlike Orkambi and T/I, the clinical improvement with these 3-drug combos in the Phase 2 and Phase 1 studes was robust. Thus, these could be impressive medical breakthrough drugs. At least one of the drugs was associated with some liver toxicity, however; investors must remember, safety matters a lot.

I expect one or two of these 3-drug combos to enter Phase 3 in the first half of next year. These studies can move along relatively rapidly. Could we be looking at a 2021 or 2022 product intro, or two product intros?

The progress on T/I and on triple drug therapy each represents a potentially important corner that Vertex may be turning in its quest to corner the market on CF drugs.

Improving on Kalydeco

VRTX has recently acquired rights to what is said to be a deuterated ("heavy hydrogen") version of Kalydeco (CTP-656) from Concert Pharmaceuticals (NASDAQ:CNCE). The cost was $160 million upfront, with maximum milestones of $90 million. This is proposed to be a longer-acting drug with at least the same effectiveness and safety as Kalydeco, with the goal of allowing therapy once daily.

We will have to wait to see precisely how VRTX moves to incorporate the former CTP-656 into its development plan.

It is nice to see the company focusing on improving its products within the one narrow therapeutic area of CF. Focus and successful risk-taking have been the keys to the successes of such biopharma stars as Celgene (NASDAQ:CELG) and Gilead (NASDAQ:GILD).

VRTX profitable in Q2 - Another corner turned?

While the large profit in Q1 was greatly flattered by the sale of oncology R&D assets, Q2 was cleaner. Product revenues were $514 million; total revenues were $544 million. R&D expenses were enormous as a percentage of revenues at $289 million. Yet, the company eked out a 7 cent per share profit. With Orkambi growing rapidly, and Kalydeco growing as well and gaining an additional 600+ patients from an FDA supplemental approval per an August 1 press release, there's every chance that SG&A can begin to shrink as a percentage of revenues; the same may or may not be true for R&D.

Note: VRTX is well known for being fantastically R&D oriented; this is in its founding DNA, so to speak. The stock has been a strong performer since its 1991 IPO despite just a few profitable quarters, with a CAGR around 14% since then. Also, over the past 10 years, despite the terrible disappointment of its hepatitis C drug, Incivek, going from best new product entrant ever in 2011 to zero after the current generation of HCV drugs began reaching the market, the CAGR for VRTX over the past 10 years is around 13%.

So, I'm not certain that conventional profits are now going to be the goal of this company versus more Amazon-like (NYSE:AMN) reinvestment. Nonetheless, that it could be profitable despite huge R&D spending strikes me as another corner turned.

But I do need to note that as usual for VRTX, analysts have marked down their EPS forecasts. These were $1.66 non-GAAP and $3.12 non-GAAP for 2017 and 2018 before the earnings report, and now are looking more like $1.60 and $3.03 respectively.

Sales are forecast to be $2.68 billion for next year; I am not certain whether that is actually a product sales forecast or total revenue forecast (I think it's total revenues).

In any case, clearly this stock is being valued on earnings some years from now, or at least potential earnings if it just spends and spends on R&D.

Why VRTX may become a more conventional earnings play

There is only one Jeff Bezos, and tech is tech. Meaning, you can have a new idea and just implement it. In the case of AMZN, a leader in profit-lite stock market/business wizardry, the story is well-known and logical. The infrastructure to support AMZN's retail division, both hardware and software, was there to allow the company to offer itself out as the repository of data from other companies and individuals; voila: AWS. Profits from retail went back into global retail expansion and into AWS expansion.

This sort of scalable and unusual set of enterprises does not translate well to pharmaceuticals. Time lines are too long, regulation too intense, breakthrough ideas of uncertain safety even if therapeutically sound, etc. In other words, beyond the evolving and impressive potential to make a huge impact in an untreatable disease, CF, it is difficult to see VRTX scaling. And since the universe of CF patients can only evolve slowly, success with the T/I combo and then triple therapy should either force the company to become a free cash flow powerhouse or else get into a good deal of acquisition activity that could bring GAAP profits way down if extensive.

Thinking it through, however, given the very high valuation of VRTX, if the institutions who own the stock want new buyers to sell their stock to, it makes sense for them to pressure the company to move toward conventional behavior and show growing GAAP (and non-GAAP) profits. This occurs over and over again, with AMZN a rare exception.

My long-term investment thesis for VRTX is, for the above two reasons, that it succeeds in dominating the CF market and becomes a "GARP" (growth at a reasonable price) stock.

Risks

Anyone interested in VRTX stock should very much consider reading the Risk Factors in the 10-K and as updated in the 10-Q and elsewhere. Past performance of the shares is no guarantee and may be no indicator of any future success for anyone purchasing shares at current prices.

Certainly, the very high prices charged by VRTX for its drugs brings risk of various sorts. And even though I think the company has a solid lead against all its competitors in the fight to bring improved drugs to the market for CF patients, only time will tell how the market develops. Can it achieve clear, profound dominance by the early 2020s, as it hopes, and extend that for many years to come? The less chances it can do that, the greater the risks to investors in the stock.

Concluding thoughts - Is VRTX another CELG in the making?

When one goes back to look at the valuation metrics of CELG in the 2005-07 period, it traded as high as about 21X sales per share. The sales and EPS growth were a lot faster than the valuation shrinkage, so that all worked out. If VRTX can beat estimates next year and trade at some point at 20X revenues of, say, $2.85 billion, that would equate to a $57 billion market cap, or a 50% price increase from that seen today.

I published my last VRTX article a little over two years ago and titled it "Vertex Pharma: Well Positioned To Set New Highs." Part of the bull thesis was that the company was a takeover target. That has not happened, but maybe it would have benefited the acquirer if it had gotten control after the stock took its big dive. The stock was around $128 then versus $154 now. That would be a 20% gain - not at all bad given that a leading biotech ETF (NASDAQ:IBB) is down roughly 20% since then.

The basic case that I can see for VRTX actually being a good new money investment over time, despite being somewhat extended right now, is that it may have a hammerlock on the CF market. If the 75,000-patient population is correct, and they continue to live longer, then that number can increase. Then, one has to think of sales in countries where CF is less common but still seen, notably Mexico and South America, and China. CF is vanishingly rare in Japan, however.

Just speculating on numbers, let us say that the total addressable CF population 10 years from now is 90,000, including some from countries not included in the current 75,000 potential patient estimate. What will be the market penetration, assuming that VRTX is correct that its medicines, if approved, will then be able to treat, say, 80,000 or so patients? If it reaches 50%, then that's 40,000 patients. With Kalydeco, which is highly effective, listing for well over $300,000 per year, and with VRTX having indicated in, I think, 2015 that discounts in the EU were not all that much greater than in the US, but Orkambi less highly priced than Kalydeco, do we estimate $200,000 per patient per year? I do not know, but that would come to $8 billion per year. If that occurs, and note again these numbers are rank speculation, it is anyone's guess whether the company will proceed as CELG has, with other products and a robust pipeline, or like GILD and Amgen (NASDAQ:AMGN), with the Street looking at aging product lines and inadequate R&D productivity and valuing the stock at a relatively low price-to-sales ratio?

Lots of questions, and no answers until the future unfolds.

At this point, now focusing almost exclusively on CF, VRTX has evolved to be my favorite sort of company, namely one with an ecosystem that is tightly tied together. CELG and GILD have done that; so has Biogen (NASDAQ:BIIB). In a different field, obviously Apple (NASDAQ:AAPL) has done that amazingly well, as has Facebook (NASDAQ:FB). The first biotech stock I wrote about and praised more than 4 years ago, United Therapeutics (NASDAQ:UTHR), accomplished something similar in extraordinary fashion. These are "category killer" companies. As with GILD in HIV/AIDS, the profit stream from CF drugs at VRTX may have, in the end, greater durability than the analysts think. Line extensions, new inventions developed in-house using the company's extensive knowledge, and often a first look at new ideas developed elsewhere can be powerful advantages. In addition, once the sales force is well trained, ethical and productive, the company has the added profit ability to market or co-market products developed elsewhere, providing a bridge over sometimes troubled waters. Finally, in the case of VRTX, its experience with rare diseases could make it a preferred senior partner for a small player with a new product, should VRTX make it to become a $5 billion+ annual sales and highly profitable company.

In summary, VRTX has taken a promising lead in the development and marketing of a once-fatal disease with no specific treatment. In rebounding so quickly from the Incivek disaster, it has proven there are some second acts. With few short-sellers (only about 1.5% of the float) and strong institutional sponsorship, the company may have the right stuff to grow into its valuations and continue to reward shareholders with price appreciation. Risks are significant, however, including but not limited to product development risks and valuation risks.

Thanks for reading and sharing any comments you wish to contribute.

Disclosure: I am/we are long VRTX, BIIB, CELG, GILD, AAPL.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Not investment advice. I am not an investment adviser.

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Vertex Pharmaceuticals May Be Turning Some Major Corners - Seeking Alpha

As previously announced, the transaction is expected to close in the fourth quarter of 2017, subject to regulatory approvals and certain other customary closing conditions.

Upon closing of the transaction, CF Corp. will change its name to FGL Holdings. Chinh E. Chu and William P. Foley, II will continue to serve as Co-Executive Chairmen, and Christopher J. Littlefield, Eric L. Marhoun and Dennis R. Vigneau, each a current member of FGL's management team, will join FGL Holdings as executive officers.

About CF Corporation

CF Corporation's primary objective is to build an enduring, high quality business by using permanent capital, a core tenet of the CF Corp. structure. CF Corp. also has the largest individual founder co-investment in a U.S. special purpose acquisition company, which results in alignment of interests with CF Corp.'s investors.

Forward-Looking Statements

This press release contains, and certain oral statements made by representatives of CF Corp. and its affiliates from time to time may contain, "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. CF Corp.'s actual results may differ from their expectations, estimates and projections and consequently, you should not rely on these forward looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "might" and "continues," and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, CF Corp.'s expectations with respect to future performance and anticipated financial impact of the business combination, the satisfaction of the closing conditions to the business combination and the timing of the completion of the business combination. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Most of these factors are outside CF Corp.'s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement relating to the proposed business combination; (2) the outcome of any legal proceedings that may be instituted against CF Corp. or FGL following the announcement of the merger agreement and the transactions contemplated therein; (3) the inability to complete the business combination, including due to failure to fulfill conditions to closing in the merger agreement; (4) delays in obtaining or the inability to obtain necessary regulatory approvals (including approval from insurance regulators) required to complete the transactions contemplated by the merger agreement; (5) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement or could otherwise cause the transaction to fail to close; (6) the inability to obtain or maintain the listing of the post-closing company's ordinary shares on NASDAQ following the business combination; (7) the risk that the business combination disrupts current plans and operations as a result of the announcement and consummation of the business combination; (8) the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably and retain its key employees; (9) costs related to the business combination; (10) changes in applicable laws or regulations; (11) the possibility that FGL or the combined company may be adversely affected by other economic, business, and/or competitive factors; and (12) other risks and uncertainties identified in CF Corp.'s proxy statement relating to the business combination, including those under "Risk Factors" therein, and in CF Corp.'s and FGL's other filings with the SEC. CF Corp. cautions that the foregoing list of factors is not exclusive. CF Corp. cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. CF Corp. does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, subject to applicable law. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

No Offer or Solicitation

This press release is for informational purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy any securities pursuant to the proposed transactions or otherwise, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

CF Corporation Contacts:

Douglas B. Newton, Chief Financial Officer CF Corporation 212-355-5515

Jonathan Keehner/Julie Oakes / Tim Ragones Joele Frank, Wilkinson Brimmer Katcher 212-355-4449

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SOURCE CF Corporation

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CF Corporation Shareholders Approve Merger with Fidelity & Guaranty Life - PR Newswire (press release)

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CF Industries Holdings, Inc. (NYSE:CF).

Van Eck Associates Corp reports that it sold 125,956 shares in the previous quarter decreasing its exposure to CF Industries Holdings, Inc. by 3.7%. Its investment stood at $91,898,000 a decrease of 8.3% as of quarter end.

Here are some other firms who have updated their holdings. As of the end of the quarter New York State Teachers Retirement System had bought a total of 1 shares growing its holdings by 0.0%. The value of the investment in CF decreased from $11,843,000 to $11,282,000 a change of 4.7% quarter over quarter. As of quarter end Thrivent Financial For Lutherans had acquired 277,080 shares growing its stake by 3,233.1%. The value of the investment in (CF) went from $252,000 to $7,987,000 a change of $7,735,000 since the last quarter.

As of the end of the quarter Citigroup Inc had acquired 55,000 shares growing its position 24.6%. The value in dollars went from $6,569,000 to $7,795,000 increasing 18.7% for the reporting period.

On July 26 the company was downgraded to Neutral from Overweight in a statement from Credit Suisse.

The company is so far trading down from yesterdays close of $30.77. The company declared a dividend that was paid on Wednesday the 31st of May 2017. The dividend was $0.300 per share for the quarter or $1.20 annualized. This dividend amount represented a yeild of $3.76. The ex-dividend date was Thursday the 11th of May 2017.

Shares of the company are trading at $30.60 which is a tad above $29.35, the 50 day moving average and which is marginally higher than the 200 day moving average of $29.72. The 50 day moving average went up $1.22 or +4.141% whereas the 200 day moving average was up $0.85 or +2.843%.

As of the latest earnings report the EPS was $-1.59 and is projected to be $-0.70 for the current year with 233,247,000 shares presently outstanding. Next quarters EPS is estimated at $-0.24 and the next full year EPS is projected to be $0.26.

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CF Industries Holdings, Inc. (CF) Investment Down in Latest Report from Van Eck Associates Corp - Modern Readers