Connecticut Business E-News

Alexion Pharmaceuticals will be likely apply for an FDA drug approval for its ALCN 1210 in 2018 to begin to replace its big moneymaker Soliris.

By Mitchell Young

NEW HAVEN: Good news for Alexion Pharmaceutials Inc. [NASDAQ: ALXN] and its researchers based in the city. The comopany announced that its “pivotal” Phase 3 study of ALXN1210, replacement drug for its main money maker Solirs ”demonstrated non-inferiority to Soliris® (eculizumab).”

In other words, ALXN1210 proved just as effective and safe as Solirs. So why the big deal, first off, the new drug extends the intellectual property life of the company’s franchise and more importantly for patients it only needs to be infused [intravenously], 6 times per year, instead of 26 for the current treatment.

Now, Alexion plans to submit applications for approval in the U.S., Europe and Japan in the second half of 2018.

convexityFAIRFIELD: Convexity Scientific Inc., a life sciences company start-up says it is “committed to bringing the best user experience to patients through innovative design and distribution of medical devices,” has closed an equity investment in a round led by Connecticut Innovations, Benslie Limited and Stonehenge Growth Capital.

Connecticut Innovations investment is $1.5 million of an estimated $3.5 million total raise.

The company says it will use the funding “to accelerate go-to-market activities with a significant expansion in sales hires and marketing efforts adding,. Convexity’s business strategy leverages its unique ability to develop health care products with innovative design and superior ease of use.”

baxdelan 1245636NEW HAVEN: Melinta Therapeutics, Inc. [NASDAQ:MLNT], announced that The Menarini Group, the privately owned Florence, Italy based global pharmaceutical company, has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Melinta’s anti-bacterial drug delafloxacin , it will marketed under the trade name Quofenix in Europe.

Delafloxacin marketed as Baxdela by Melinta in the US is for the treatment of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Delafloxacin was approved by the FDA on June 1, 2017.

Artificial Cell Technologies Inc., CFO has been indicted for embezzlement from the company.

NEW HAVEN: The chief financial officer of Artificial Cell Technologies Inc, .a Science Park based biotech receiving federal research grants was charged with embezzling nearly $1 million from the company. Thomas Malone of New Haven was arraigned before United States Magistrate Judge Sarah A. L. Merriam and was released on a $50,000 bond.

ACT is developing malaria and respiratory syncytial virus vaccines, the company reportedly has nine employees and has received funding from private investors and approximately $4.1 million in SBIR grants from the National Institutes of Health since 2008.

ZYDIS S Catalent 0282 v2NEW HAVEN: Biohaven Pharmaceutical Holding Company Ltd. [NYSE:BHVN] has entered into an exclusive worldwide license agreement with Catalent U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc. [CTLT] ("Catalent") to provide Catalent's Zydis® ODT (orally disintegrating tablet) fast-dissolving formulation for the development of Biohaven's lead calcitonin gene-related peptide (CGRP) receptor antagonist product candidate, rimegepant.

The agreement also provides exclusive rights for developing small molecule CGRP receptor antagonists with the Zydis ODT technology. Catalent's proprietary Zydis technology is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water. With more than 20 products launched in 50 countries and a dispersion speed of three seconds or less, the company says “Zydis ODT is the world's fastest and best-in-class orally dissolving tablet.”

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CEO Millind Deshpande, "focused on ..Factor D portfoilio." Joseph Truitt named as Chief Operating Office

NEW HAVEN: Achillion Pharmaceuticals, Inc. [NASDAQ:ACHN} is reducing its workforce to 70 a decrease of 20% in what it is calling an “operational restructuring plan that aims to focus the organization on advancing Achillion’s existing clinical and late-stage preclinical factor D inhibitors and reduce expenses to maintain its strong balance sheet.”

The plan is hoped to deliver “approximately $10 million of savings in 2018 over 2017 expense levels.

In addition, the Company announced that Joseph Truitt has been promoted to President and Chief Operating Officer, continuing to report to Chief Executive Officer, Milind Deshpande, Ph.D.

bioxcelBRANFORD: How’s this for Start-up speed, BioXcel Therapeutics, founded less than a year ago, is launching a $69 million IPO.

The company says it uses “big data” and machine learning to find new drug therapies.

“We believe that this differentiated approach has the potential to reduce the cost and time of drug development in diseases with substantial unmet medical need,” the company said in a statement.

The Nasdaq Capital Market under the ticker symbol “BTAI.