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Thursday, December 12, 2019

Opiant nabs second tranche of BARDA contract for nasal nalmefene

U.S. Health and Human Services unit BARDA has awarded the second tranche of its contract with Opiant Pharmaceuticals (NASDAQ:OPNT), valued at ~$2.4M, to accelerate the development of nasal nalmefene for the potential treatment of opioid overdose.
The total agreement is valued up to a maximum of ~$4.6M, the balance to be funded next year.
The company expects to file a U.S. marketing application in Q4 2020.

Sarepta spikes after accelerated FDA approval of Duchenne treatment

Sarepta Therapeutics (NASDAQ:SRPT+23.4% after-hours on news the Food and Drug Administration granted accelerated approval to the company’s Vyondys 53 (golodirsen) injection to treat a rare Duchenne muscular dystrophy mutation.
In making its decision, the FDA says it considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease and the lack of available therapy.
As part of the accelerated approval process, the FDA requires SRPT to conduct a clinical trial to confirm the drug’s clinical benefit.

Pharma fury as Trump’s team reneges on biologic patent rules in trade talks

A key part of president Donald Trump’s strategy to cut drug prices was to attack global “freeloading” for pharmaceuticals, targeting countries pushing back against pharma c
But in trade negotiations with Canada and Mexico, it looks like that the Trump administration has not followed through on the strong rhetoric set out in his drug pricing strategy published last year.
According to press reports Trump’s negotiating team have agreed to scrap provisions on exclusivity of biologics, allowing each country to decide when the patent protection period expires on biologics.
In the US, biologics typically get 12 years of exclusivity without patent thickets and the new trade pact was set to provide 10 years of protection across the three markets.
The decision was celebrated by Democrats, who argued that locking in the 10 year protection period would have prevented Congress on setting its own rules on drug prices in the future.
Democratic representative for Illinois’s 9th district Jan Schakowsky and drug price campaigner, said in a press conference: “The Trump administration tried to tuck in big corporate gifts to Big Pharma. This trade bill would have tied Congress’s hands and prevented us from enacting legislation. But that provision is now out of the trade deal. It is gone.”
But the changes did not wash well with the US pharma industry, which argued that the removal of the provision sets a “dangerous precedent” for future trade talks including with China.
By risking a potentially shorter period of patent protection on biologics, the new deal puts US jobs, intellectual property and leadership in medical innovation at risk, said the US Biotechnology Industry Organization.
President and CEO Jim Greenwood said in a press statement: “President Trump has promised to end foreign free-riding on American medical innovation, but by removing enhanced IP protections for biologic medicines, his administration just surrendered one of the most important tools that would help stop it.”
The issue of biologics pricing came up in leaked documents of post-Brexit trade negotiations between the US and UK.
According to the documents trumpeted by opposition leader Jeremy Corbyn in the run-up to the election, Trump’s representatives “pushed hard” for harmonisation of UK biologic patent laws with those in the US.
Biologics are complex drugs manufactured in living cells, and are often more expensive than conventional medicines made in factories.

FDA OKs PerkinElmer Duchenne test

The FDA approves PerkinElmer’s (PKI +1.2%) GSP Neonatal Creatinine Kinase-MM kit as an aid to newborn screening for Duchenne muscular dystrophy (DMD).
Based on a heel stick sample, the test measures the concentration of a type of protein called CK-MM which is elevated when muscles are damaged.

Sangamo adds to ST-400-stoked selloff, down 1%

Sangamo Therapeutics (SGMO -1%) is down again, albeit modestly on average volume. Shares have sold off over 30% since touching $12.33 on Monday.
Investors appear to be reacting to preliminary results from a Phase 1/2 clinical trial, THALES, evaluating cell therapy ST-400 in beta thalassemia patients. The data were presented at ASH in Orlando on that day.
Two patients had been infused. One experienced a serious adverse event, hypersensitivity, deemed related to ST-400’s cryoprotectant DMSO that resolved by the end of infusion. On the efficacy front, the patient was transfusion-free for only six weeks. More time will be needed to assess the treatment effect on the second patient.
For comparison purposes, results from a Phase 1/2 study evaluating bluebird bio’s (BLUE -1.7%) LentiGlobin gene therapy in transfusion-dependent beta-thalassemia patients showed a median transfusion-free period of 33 months in eight patients. Preliminary data on seven subjects in a Phase 3 trial showed transfusion-free periods of 4.7 – 15.1 months.
#ASH19

3M to Divest Substantially All Drug Delivery Business to Altaris Capital

3M today announced that it has entered into an agreement to sell substantially all of its drug delivery business to an affiliate of Altaris Capital Partners, LLC. Subject to closing and other adjustments, 3M will receive approximately $650 million in total consideration, including cash, an interest-bearing security, and a 17 percent noncontrolling interest in the new company.
The business is a global leader in drug delivery that partners with pharmaceutical and biotech companies to develop and manufacture pharmaceutical products using unique inhalation, transdermal, microneedle, and conventional drug delivery technologies. 3M will retain its transdermal drug delivery components business. The business that is being divested has annual global sales of approximately $380 million.
“The drug delivery business is a leading provider of transdermal and inhalation delivery technologies,” said Michael Roman, 3M chairman and chief executive officer. “This transaction will allow us to focus more resources on our core health care business as well as retain a share in the value of the drug delivery business as it grows over the coming years.”
The transaction, which is subject to customary closing conditions and regulatory approvals, is expected to close in the first half of 2020. Approximately 900 3M employees, who primarily support the business, are expected to join the new company upon completion of the sale.
3M expects to realize a gain of $0.45 to $0.50 per share from this transaction, net of actions related to the divestiture. Upon completion of the transaction, 3M’s ownership interest in the drug delivery business will be reported using the equity method of accounting.
Morgan Stanley & Co. LLC acted as financial advisor to 3M. Cleary Gottlieb Steen & Hamilton LLP acted as legal counsel to 3M.

Lannett To Commence Marketing Generic Adderall® XR

Lannett Company, Inc.  (NYSE: LCI) today announced that it expects to commence marketing in the coming months a generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine tablet product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate), with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg tablets. Adderall XR® including generic versions have an estimated IQVIA market value of approximately $1.3 billion for the 12 months ending October 2019, although actual generic market values are expected to be lower.

“Our strategic alliance partners already have received FDA approval for generic Adderall XR®, paving the way for a near-term launch,” said Tim Crew, chief executive officer of Lannett. “Generic Adderall XR® complements our previously launched generic Adderall® immediate release (IR) and is included in the dozen or so products we expect to launch by the end of our current fiscal year. While the Adderall XR market is sizable, there currently are several generic suppliers for this product.”
In March 2019, Lannett entered into an agreement with Elite Pharmaceuticals and SunGen Pharma to be the exclusive U.S. distributor of certain drug products, including generic Adderall® IR and generic Adderall XR®. Under the agreement, Lannett primarily provides sales, marketing and distribution support for the products, for which it receives a share of the profits.
Adderall XR®, a registered trademark of Shire Plc, is a central nervous system (CNS) stimulant, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.