Global Pharma Briefs: News from Europe and the US

By Miranda Greenberg -

September 3, 2020

A roundup of news from the UK (Takeda, Engitix Therapeutics, Intract Pharma, Celltrion), and the US (Gilead Sciences, Jounce Therapeutics, Mylan, Biocon, and Ionis).

UK

Takeda, Engitix in $500-M Pact To Develop Anti-Fibrotic Therapies
Engitix Therapeutics, a London-headquartered biopharmaceutical company developing treatments for fibrosis and solid tumors, has entered into a licensing and collaboration agreement with Takeda to discover and develop novel therapeutics for advanced fibrotic liver diseases, including non-alcoholic steatohepatitis (NASH), in a deal worth over $500 million. NASH is an advanced form of non-alcoholic fatty liver disease caused by the buildup of fat in the liver.

Under the agreement, Engitix and Takeda will collaborate in the confirmation and validation of targets and preclinical development of therapeutics in liver fibrosis using Engitix’s extracellular matrix discovery platform. Takeda will have exclusive rights to develop and commercialize clinical candidates generated against validated targets derived from the collaboration. Engitix will receive an upfront payment, with additional near-term payments based on the confirmation and functional validation of selected targets. Engitix will be eligible to receive more than $500 million for the achievement of preclinical, development, regulatory, and commercial milestones as well as further royalty payments upon sales of commercialized products.

Source: Engitix Therapeutics


Celltrion, Intract Pharma in Pact to Develop Oral Version of J&J’s Remicade
Intract Pharma, a London-based oral drug-delivery licensing and product development company, has entered into a joint development agreement with Celltrion, an Incheon, South Korea-based biopharmaceutical company developing innovator drugs and biosimilars, for an oral version of Johnson & Johnson’s Remicade (infliximab) for treating inflammatory bowel disease (IBD).

The oral infliximab product has been cleared by the UK regulatory body (MHRA) to proceed to Phase Ib/IIa clinical trials in IBD patients during the second half of 2021, without the requirement for further preclinical research or a clinical safety study.

The oral product, along with intravenous and subcutaneous formulations (Remsima IV and Remsima SC) are expected to secure Celltrion’s position in the TNF-α inhibitor market. Development of the product through clinical validation will be the responsibility of Intract, with support, including supply of drug material for generation of the oral product, from Celltrion Celltrion retains the right to complete clinical development of the product following completion of Phase II clinical trials and to take the product to market.

Source: Intract Pharma


US

Gilead, Jounce Therapeutics in $805-M Pact for Immunotherapy
Gilead Sciences has announced an agreement with Jounce Therapeutics, a Cambridge, Massachusetts-based immuno-oncology company, to exclusively license Jounces’ monoclonal antibody program, JTX-1811, in a deal worth up to $805 million.

JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. The antibody remains on track for the filing an investigational new drug (IND) application in the first half of 2021.

Under the agreement, Gilead will make a $85-million upfront payment and take a $35-million equity investment in Jounce. In addition, Jounce may receive up to an additional $685 million in future clinical, regulatory, and commercial milestone payments. Jounce will also be eligible to receive royalties ranging from high single digit to mid-teens based upon worldwide sales, subject to certain adjustments.

Jounce will lead development of JTX-1811 through IND clearance, and thereafter, Gilead will have the sole right to develop JTX-1811.

This transaction, which is expected to close in the second half of 2020, is subject to applicable antitrust clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

Source: Gilead Sciences


Mylan, Biocon Biologics Launch of Generic Diabetes Drug in the US
Mylan and Biocon Biologics India, a biosimilars company and a subsidiary of Biocon, have announced the US launch of Semglee (insulin glargine injection) in vial and pre-filled pen presentations and approved to help control high blood sugar in adult and pediatric patients with Type 1 diabetes and adults with Type 2 diabetes.

Semglee, which received final approval from the US Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi’s Lantus (insulin glargine) and is approved for the same indications.

Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3-mL pens and $98.65 per 10-mL vial. Additionally, Mylan has submitted to the FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway to seek an interchangeability designation.

The launch follows favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products, according to Mylan.

Sanofi's total sales for the 12 months ending June 30, 2020 were approximately $1.64 billion for Lantus 100 units/mL vial and approximately $4.36 billion for the Lantus SoloSTAR Pen, according to IQVIA and as reported by Mylan. Mylan and Biocon Biologic's insulin glargine has received regulatory approval in more than 45 countries globally and is the third product approved by the FDA through Mylan’s and Biocon Biologics’ biosimilars collaboration.

Source: Mylan and Biocon


Ionis Pharmaceuticals To Acquire Remaining Stake in Akcea Therapeutics
Ionis Pharmaceuticals, a Carlsbad, California-based pharmaceutical company, and its affiliate Akcea Therapeutics, specializing in drugs for rare diseases, have entered into a definitive agreement under which Ionis will acquire all of the outstanding shares of Akcea common stock it does not already own, approximately 24%, for $18.15 per share in cash.

This corresponds to a total transaction value of approximately $500 million on a fully diluted basis. The transaction has been approved by the Ionis and Akcea Boards of Directors, and by the independent Affiliate Transactions Committee of Akcea's Board of Directors. Akcea's Board of Directors has recommended to shareholders of Akcea that they tender their shares into the tender offer.

Under the agreement, Ionis will commence a tender offer for all outstanding shares of Akcea common stock not already owned by Ionis at a price of $18.15 per share in cash. The closing of the tender offer will be subject to a majority of Akcea's shares not already owned by Ionis, its affiliates or their respective directors and executive officers being tendered in the tender offer. Following the completion of the tender offer, Ionis will acquire all remaining shares of Akcea common stock at the same price of $18.15 per share in cash through a second-step merger. Ionis and Akcea expect to complete the transaction in the fourth quarter of 2020, subject to other customary closing conditions.

Source: Ionis Pharmaceuticals and Akcea Therapeutics