Kitov Osteoarthritis Pain-Hypertension Combo Med OKd by FDA

Kitov Pharma Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Consensi™ (amlodipine and celecoxib) oral tablets for marketing.

Consensi™ is a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker. Consensi™ was approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.

“We are very pleased with Consensi™’s approval and would like to thank the members of Kitov’s team, consultants and investigators, as well as the FDA’s Division of Cardiovascular and Renal Products, for all of their support and assistance,” said Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer. “Consensi™ provides a safe and effective combination treatment option for the millions of Americans who suffer from osteoarthritis pain and hypertension.

“Now that Consensi™ has been approved for marketing, our clinical and regulatory teams will focus on leveraging their drug development expertise to advance NT219, an exciting investigational new drug candidate currently in development for various oncology indications.”

Isaac Israel, Kitov’s CEO, added: “This approval demonstrates the Kitov team’s ability and experience in expertly guiding Consensi™ through clinical trials and regulatory review, from Investigational New Drug (IND) submission to FDA approval in less than four years.

“Over 50 million Americans suffer from osteoarthritis. About 1 of 3 U.S. adults or about 75 million people have high blood pressure*, known as the “silent killer” due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi™, as a single pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.

“We recently expanded our commercialization network for Consensi™ by securing a second licensing agreement in Asia with a major Chinese pharmaceutical company. The FDA approval of Consensi™ puts us in a stronger position towards securing commercial partnerships for the U.S. and other key territories.”

The FDA-approved Consensi™ New Drug Application included the positive results from the Company’s Phase III clinical trial. These data demonstrated that the study met its primary endpoint of showing that the drug lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only, with statistical significance of p=0.001. Kitov also submitted the positive results from its randomized double-blind, placebo-controlled renal function Phase III/IV clinical trial of Consensi™. Data from this study validated the primary efficacy endpoint achieved in the completed Phase III clinical trial. This study also demonstrated that treatment with Consensi™ led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005), demonstrating improved renal function in patients treated with the combination. In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.

https://yhoo.it/2H5PYqJ

Abbott announces corrective action for HeartMate 3 heart pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device, according to a statement on the FDA’s website. Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting. No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by Abbott remain in place for physicians managing patients implanted with HeartMate 3. Abbott is currently aware of 32 reports of outflow graft twisting in 4,467 HeartMate 3 devices worldwide, including reports of low blood flow, clotting, and three reported deaths that could be associated with outflow graft twisting. As a result, Abbott has contacted physicians managing patients implanted with a HeartMate 3 LVAD in the event their patients report persistent low flow alarms that could indicate outflow graft twisting. Twisting of the outflow graft can occur at any point after implant.

https://bit.ly/2kCTVKD

Mass layoffs at IBM Watson Health

IBM (NYSE:IBM) has reportedly laid off 50% to 70% of the workforce at its Watson Health operation, primarily at recent acquisitions for which Big Blue paid at least $3.6B.

Those include cloud-based services Explorys and Phytel, as well as medical image company Merge Healthcare and Truven Health Analytics.

One former employee wrote “the message was that there are about 7,000 people in Watson Health today and this was a cost-cutting exercise.”

Statement from IBM: IBM is continuing to reposition our team to align with our focus on the high-value segments of the IT market.  We continue to hire aggressively in critical new areas that deliver value for our clients and IBM.

We’re not discussing specific numbers of employees affected, but it’s a small percentage of our global Watson Health workforce, as we move to more technology-intensive offerings, simplified processes and automation to drive speed.

https://bit.ly/2LKMmxM

Alder target for Allergan, Biogen? RBC

Developments at Allergan, Biogen indirectly positive for Alder, says RBC Capital. RBC Capital analyst Brian Abrahams noted that both Allergan (AGN) and Biogen (BIIB) have been viewed as companies that could potentially be interested in acquiring or partnering with Alder Biopharmaceuticals (ALDR) and he makes the case that developments in the past day or so for both of those large-cap drugmakers are indirectly positive for Alder. In terms of Allergan, Abrahams thinks the company stating that it plans to keep a primary care infrastructure to sell CGRPs and other CNS products maintains the likelihood they might have interest in Alder’s eptinezumab either as an acquisition or in a partnership. In terms of Biogen, Abrahams thinks the company’s hiring of a leader for a newly-created corporate development function who has extensive experience in business development potentially lays the groundwork for them to explore assets such as eptinezumab. The analyst maintains an Outperform rating and $24 price target on Alder shares.

https://bit.ly/2svRdtV

Alzheimer’s Firm Cortexyme Closes $76M Financing with Pfizer, Takeda, Google

South San Francisco-based Cortexyme closed on a $76 million Series B financing round. New investors included Sequoia Capital, Vulcan Capital, Verily Life Sciences (a Google/Alphabetcompany), EPIQ Capital Group, RSL Investments, Huizenga Capital, and one of the largest long-term mutual funds in the world. The company’s current investors also participated, including Pfizer, Takeda, Ventures, Lamond Family, Breakout Ventures, and Dolby Family Ventures.

In addition to the financing, the company reported it had completed a placebo-controlled single ascending dose trial and multiple ascending dose trial in healthy patients of COR388, the company’s lead compound to treat Alzheimer’s disease. The drug is a first-in-class, oral bacterial protease inhibitor that targets a specific pathogen discovered in the brains of patients with Alzheimer’s. It was originally discovered by the company’s co-founder and chief scientific officer, Stephen Dominy.

The company has engineered the compound to inhibit the pathogen in ways that a broad spectrum antibiotic can’t. It has the potential to rescue neurons from bacterial toxicity, which might prevent more cognitive decline in Alzheimer’s patients.

“Alzheimer’s has been a major medical and societal challenge for decades, and new approaches are clearly needed,” said Michael Dixon partner at Sequoia Capital, in a statement. “Cortexyme is approaching an old problem in a whole new way—moving upstream to target an underlying driver of disease. Sequoia is pleased to partner with the Cortexyme team as they move through Phase I clinical development and rapidly plan for later-stage trials to address conditions that affect millions of patients worldwide.”

Cortexyme began its existence in Johnson & Johnson’s JLABS accelerator facility in the Bay Area. Its successful completion of animal studies and a Phase I safety study in older healthy individuals lays the groundwork for a Phase II human clinical trial.

The predominant approach to Alzheimer’s drugs is focused on beta-amyloid, a protein plaque that accumulates in the brains of Alzheimer’s patients. Although still the leading theory, study after study has failed in Phase II and Phase III trials, typically for lack of efficacy. It has cast doubt on the beta-amyloid theory, at least among investors if not necessarily in the minds of scientists.

As recently as May 18, Johnson & Johnson shuttered a clinical trial of atabecestat, a BACE inhibitor, for Alzheimer’s disease. Instead of issues with efficacy, the program was halted because of safety issues. BACE1 is an enzyme involved in creating beta-amyloid.

Other recent high-profile Alzheimer’s failures include Merck & Co’s verubecestat, Axovant’s intepirdine, Eli Lilly’s solanezumab, Lundbeck’s idalopirdine and many others.

Cortexyme’s approach is different and caught the attention of a number of marquis investors. Casey Lynch, Cortexyme’s co-founder and chief executive officer stated, “Cortexyme is glad to count among its supporters some of the world’s most successful investors in innovation, both in the pharmaceutical industry and beyond. Our streamlined, efficient approach to drug development allowed us to move from seed funding to Phase I data in less than four years. We’re committed to continuing to move swiftly through Phase II proof of efficacy studies in service of bringing new therapies to patients suffering from Alzheimer’s and related conditions.”

https://bit.ly/2sv8HXt

Biogen poaches Pfizer dealmaker Dan Karp for stepped-up M&A push

Want to get serious about business development? Take a page from Pfizer’s playbook—and that’s exactly what Biogen is doing.

On Thursday, the big biotech said it had brought on Pfizer veteran Dan Karp as its EVP of corporate development, ending his stint as the pharma giant’s VP of worldwide business development and head of R&D business development. For Biogen, Karp will lead a newly minted “corporate development function,” spanning business development and corporate strategy, the company said.

Read: Dealmaking, at a time when Biogen needs to continue racking up transactions to beef up R&D and revenue both.

Pfizer, never one to shy away from a transaction and famous for its willingness to jump into a megamerger, sees plenty of deal activity, which is just what Biogen’s seeking. The company touted Karp’s “strong track record of success leading licensing and M&A transactions,” while CEO Michel Vounatsos—to whom Karp will directly report—praised the “solid experience” that will “serve him well in this exciting position as we aim to further build our pipeline and portfolio.”

Biogen is looking for new revenue streams as competition to its multiple sclerosis portfolio heats up. Last year, Roche piled on the pressure with the approval of blockbuster-to-be Ocrevus, and forthcoming generic versions of Gilenya—a Novartis rival to Biogen’s oral star Tecfidera—will make matters worse next year.

Last April, the company shelled out $300 million upfront and up to $410 million in milestones to gain access to a Bristol-Myers Squibb’s progressive supranuclear palsy and Alzheimer’s candidate, a move R&D head Michael Ehlers called “just the beginning of a set of very rigorous but highly active deals.”

And since then, it’s struck a series of other deals, including buys of Remedy’s phase 3 stroke drug and Karyopharm’s neurology and inflammation candidate, as well as a $1 billion pact on discovery-stage R&D with Ionis. Earlier this year, rumors also listed Biogen as a potential buyer for activist-pressured Acorda, though so far no deal has taken place.

https://bit.ly/2LOdBr9

Cantel Medical trims FY18 sales growth outlook to 12.5%-13.0%

Cantel Medical in earnings call presentation slides lowered its sales growth outlook for fiscal 2018 to 12.5%-13.0% from 13.0%-14.0%. Sales are at the lower end of the company’s guidance for fiscal year 2018 and in line with its five-year strategic plan, it noted. Cantel revised its fiscal 2018 earnings per share outlook to $2.47-$2.50. The company sees a net tax benefit for the year of 14c-15c. Shares of Cantel Medical are down 8% to $119.81 in morning trading.

https://bit.ly/2kHsz5X