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Thursday, December 12, 2019

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.

Walgreens Boots Alliance and McKesson team up in Germany

Aimed at achieving better scale, Walgreens Boots Alliance (NASDAQ:WBA) and McKesson (NYSE:MCK) will combine their respective wholesale businesses in Germany, Alliance Healthcare Deutschland and GEHE Pharma Handel.
WBA will own 70% of the joint venture (JV) while MCK will own 30%.
The transaction should close in six months or more. Financial terms are not disclosed.

Merck’s Keytruda extends survival in first-line lung cancer

An exploratory analysis of the Phase 3 KEYNOTE-042 clinical trial evaluating Merck’s (NYSE:MRK) Keytruda (pembrolizumab) as monotherapy versus chemo for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) with at least 1% PD-L1 expression regardless of KRAS mutation status showed improvements in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR). The results were presented at ESMO IO in Geneva.
In patients with any KRAS mutation (present in ~20% of NSCLC cases), median OS in the Keytruda group was 28 months compared to 11 months for chemo. In patients with no KRAS mutations, OS also favored Keytruda, 15 months vs. 12 months.
Median PFS in patients with any KRAS mutation was 12 months for Keytruda compared to six months for chemo. Median PFS was six months for both in patients with no KRAS mutations.
ORR was 56.7% for Keytruda vs. 18.0% for chemo in patients with any KRAS mutation. ORR was higher for Keytruda, 29.1% vs. 21.0%, in patients with no KRAS mutations.