BioXcel Therapeutics announced the formation of a Clinical Advisory Board, or CAB, to provide strategic counsel to the company as it advances the development of BXCL501, a first-in-class sublingual thin film formulation of Dexmedetomedine, for the treatment of agitation. Additionally, the CAB will support the advancement of further candidates in BTI’s emerging neuroscience pipeline identified through its artificial intelligence innovation lab partnership with BioXcel Corporation. The initial members of the CAB include: Prof. Sheldon H. Preskorn, M.D.; Prof. Stephen Marder, M.D.; Dr. George Grossberg, M.D. and Prof. Alan Breier, M.D. The Company expects to add other neuroscience leaders going forward.
Tuesday, July 10, 2018
Krystal called ‘underappreciated’, started at buy by Blair
William Blair starts ‘underappreciated’ Krystal Biotech at Outperform. William Blair analyst Raju Prasad initiated coverage of Krystal Biotech with an Outperform rating and $29 fair-value estimate. The company is developing novel gene therapies for skin diseases, and its lead candidate KB103 is in a Phase I/II trial for the treatment of dystrophic epidermolysis bullosa, Prasad tells investors in a research note titled. The analyst believes the shares offer a positive risk/reward profile ahead of clinical data expected by year-end given KB103’s mechanism of action and preclinical data. If approved, KB103, could generate $500M in worldwide revenue by 2028, Prasad predicts. He views Krystal Biotech as an “underappreciated gene therapy company.”
Cerner cut to sell by Evercore
Cerner downgraded to Underperform at Evercore ISI on business mix shift. As reported earlier, Evercore ISI analyst Ross Muken downgraded Cerner to Underperform from In Line and lowered his price target to $55 from $57. The analyst notes that much of the investment debate has centered around the “population health opportunity, and the potential contribution from the optically sizable DoD and VA contracts”, but his deeper look into the company unveiled the threat coming from a business model shift to SaaS/cloud, depressing revenue growth and margins for many legacy software vendors. Muken also ctites a “potential incremental competitive threat from ‘Big Tech’ and emerging venture backed vendors in population health and other analytical adjacencies” amid a push toward interoperability which opens data monopolies that Cerner currently enjoys
BioCryst’s stock jumps, Idera drops as proposed merger called off
Shares of BioCryst Pharmaceuticals Inc. BCRX, +0.00% and Idera Pharmaceuticals Inc. IDRA, -0.72% were active in the extended session Tuesday following a brief halt after BioCryst shareholders voted down a merger between the two drug companies. BioCryst shares rallied 7.5% after hours, following flat trade Tuesday to close at $6.14. Idera shares dropped 16% after hours, following a 0.7% decline to close the regular session at $1.37. BioCryst said it would reimburse Idera for $6 million in transaction-related expenses as a result of terminating the merger agreement, which was announced in January. As of Tuesday’s close, BioCryst shares had advanced 9.8% since the January announcement, while Idera shares had fallen 46%.
Hikma grabs regional rights to 30-plus Perrigo OTC drugs, with option for more
Here’s what one product collaboration can lead to. After partnering on an allergy spray with Perrigo, Jordan-based generics player Hikma has snapped up rights to 30-plus Perrigo products in the Middle East and North Africa.
Through a new licensing and distribution deal cut with Omega Pharma, a European OTC drugmaker Perrigo bought in 2015 for $4.6 billion, Hikma will sell more than 30 consumer health products by Perrigo—including nutrition supplement Davitamon, allergy spray Prevalin, weight loss helper XLS Medical, skin treatment Dermalex and lice fighter Paranix.
In addition, Hikma has the right to first engage with Perrigo to expand the deal to all other Perrigo over-the-counter medicines sold in the region.
The Middle East and North Africa (MENA) region is without doubt Hikma’s playground; after all, it is headquartered in Jordan, a natural geographic advantage that makes it a partner of choice in the region. For 2017, the MENA market made up a third of Hikma’s total revenue of $1.94 billion.
Hikma has a substantial local presence with operations in 17 markets, including FDA-approved manufacturing sites in Jordan and Saudi Arabia, and a 2,000-member-strong sales and marketing team experienced in consumer health. Hikma said in a release that it aims to work with Perrigo’s existing partners there to expand coverage.
This is not the first time the two companies have partnered up. Through its wholly owned subsidiary West-Ward Pharmaceuticals, Hikma in 2016 worked with Perrigo to gain approval and then launch a fluticasone spray, an equivalent of GlaxoSmithKline’s Flonase.
Both companies have been cutting back lately amid an industrywide generics struggle, especially in the U.S. market. Last year, Perrigo went through a round of layoffs as part of a larger cost-saving plan. All together, 750 employees were let go, representing about 14% of its nonproduction workforce.
Last fall, Hikma said it would consolidate production operations in Jordan and Ohio and close a plant in Eatontown, New Jersey, costing about 250 jobs. After former Teva generics chief Siggi Olafssonlanded as Hikma’s new CEO early this year, the company revealed that it is looking to cut an additional 200 positions.
In a recent setback, Hikma and its partner Vectura joined a long list of companies that had their copies to GlaxoSmithKline’s respiratory stalwart Advair turned down by the FDA. The agency’s request for an additional clinical study could delay the pair’s generic version until 2020, Vectura said in March.
CMS quietly cancels plan for indication-based pricing on Novartis’ Kymriah
When Novartis won its groundbreaking CAR-T approval last year, both the drugmaker and U.S. officials touted performance-based pricing as a way to help fund the $475,000 drug. Now, the Centers for Medicare & Medicaid Services has quietly backed away from a plan to implement a novel contract for Kymriah.
Officials cancelled the plan after it drew internal HHS scrutiny, Politico reports. The plan has also come under fire from Democrats in Congress after revelations that Novartis paid President Donald Trump’s personal attorney Michael Cohen $1.2 million for healthcare consulting. A Novartis representative told the publication the Cohen arrangement had nothing to do with drug pricing.
In an email to FiercePharma, Novartis spokeswoman Julie Masow said the company’s outcomes-based contract with treatment centers “remains in effect.” It’s a voluntary agreement that only allows for payment when patients respond by the end of the first month. CMS is not a party to that deal, however. CMS has canceled a “pilot demonstration program on CAR-T indication-based pricing,” she said.
“CMS was exploring a demonstration program, one aspect of which would potentially reimburse treatment centers for CAR-T therapies based on the indication and the indication-based price,” Masow said via email. She said based on the government’s recent drug pricing blueprint, CMS “continues to be interested in this approach.” Even without the CMS program, treatment centers can still secure Kymriah reimbursement from Medicare or Medicaid.
A CMS spokesman said the agency “reviewed Novartis’s proposed demonstration and then decided to go in a different direction.”
CMS “considers proposals from a wide range of stakeholders during the policymaking process–each discussion helps deepen our understanding,” he said. The agency is still committed to “moving to value-based payment for high-cost drugs and therapies,” according to the spokesman.
Last summer, Kymriah became the first CAR-T drug to win an FDA approval. The new class of drugs, which are made from a patient’s own immune cells, can provide a cure for patients who previously had few or no other options. At the time, Novartis and CMS said they were working on novel contracting strategies to help the government pay for the treatment.
According to Politico, the CMS announcement, which came the same day as Novartis’ approval, was a departure from agency protocol. Administration attorneys became worried about how much Novartis was influencing the proposal, according to the publication. CMS canceled the plan earlier this year, according to Politico.
Then, in May, Novartis came under scrutiny for paying Cohen $1.2 million for a consulting deal. In response, Novartis said it paid Cohen because it thought he could “advise the company as to how the Trump administration might approach certain US healthcare policy matters, including the Affordable Care Act.” After its first meeting with Cohen, Novartis said it determined Cohen couldn’t provide assistance. Novartis made monthly payments of $100,000 for one year—until February 2018—and let the deal run out rather than cancelling it for cause.
The company’s answers weren’t enough for critics, including Sen. Ron Wyden, D-Ore., who reached out to CEO Vas Narasimhan seeking more details about the deal. Kymriah was among the topics Sen. Wyden probed. He wrote that the Senate Finance Committee must “ensure that pharmaceutical companies providing services to federal health programs are conducting business in a legal and transparent manner.”
CMS’ move to cancel the novel contracting effort also marks a setback to the Trump administration’s work to lower drug costs. In May, the administration unveiled its plan to lower prices, including an “immediate action” to experiment with value-based purchasing in federal drug programs and to remove regulatory barriers to the contracting model. Aside from that effort, the administration’s plan also pushes more competition, more negotiation, incentives to lower list prices and efforts to lower out-of-pocket costs.
Akorn lower after Fresenius questions computer system security
Shares of Akorn (AKRX) are moving lower on day two of the company’s court battle with Fresenius (FSNUY) over its proposed buyout at $34 per share. A review of Akorn’s computer system by a consultant hired in 2016 found the company’s security was so lax that any employee or vendor could review or change drug-testing data, a lawyer for Fresenius claimed today in court, according to Bloomberg. Shares of Akorn are down 3%, or 56c, to $18.02 in late morning trading.
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