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The Daily Biotech Pulse: Aevi's ADHD Drug Flunks Mid-Stage Trial, Bristol-Myers To Buy Celgene, Teva Settles With Amgen

The Daily Biotech Pulse: Aevi's ADHD Drug Flunks Mid-Stage Trial, Bristol-Myers To Buy Celgene, Teva Settles With Amgen

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Bristol-Myers Squibb To Acquire Celgene; Gets FDA Approval For Expanded Indication For Sprycel

Bristol-Myers Squibb Co (NYSE: BMY) announced a deal to buy Celgene Corporation (NASDAQ: CELG) in a cash and stock transaction with an equity value of approximately $74 billion.

Separately, the company announced FDA approval for an expanded indication for its Sprycel tablets to include the treatment of pediatric patients one year of age and older, with newly diagnosed Philadelphia chromosome-positive, or Ph+, acute lymphoblastic leukemia in combination with chemotherapy.

Sprycel has already been approved for use in pediatric patients one year and older with Ph+ chronic myeloid leukemia in chronic phase.

Aevi Genomic's ADHD Drug Phase 2 Trial Fails To Meet Primary Endpoint

Aevi Genomic Medicine Inc (NASDAQ: GNMX) said its ASCEND Phase 2 trial that evaluated orally administered AEVI-001 in children aged 6-17 years with attention deficit hyperactivity disorder, or ADHD, with or without an mGluR copy variant, did not achieve statistical significance on the primary endpoint of reduction of ADHD-RS after six weeks of treatment.

However, AEV-001 was found to be safe and well tolerated in both Part A (patients with a mGluR copy variant) and Part B (patients without a mGluR copy variant) treatment groups.

The company said it plans a full review of data with its scientific advisors in the coming days and consider its options.

The stock shed 64.95 percent to $0.27 in after-hours trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates

Teva Settles With Amgen Regarding Para-thyroid Drug

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said it has settled its ongoing patent infringement dispute with Amgen, Inc. (NASDAQ: AMGN) over the former's generic cinacalcet HCl product.

Cinacalcet is Amgen's calcium-sensing receptor antagonist approved for secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. It is also used to treat hypercalcemia in adult patients.

Teva, which recently received approval for a generic version of the drug and launched it in the U.S., has now agreed, as part of the settlement, to stop selling the generic version until its license date in mid-year 2021, or earlier under certain circumstance, and to pay Amgen an undisclosed amount.

Teva lost 2.21 percent to $15.50 in after-hours trading.

Ironwood, Allergan Reaches Settlement With Mylan For Constipation Drug

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN), which market Linzess in the U.S. for treating irritable bowel syndrome with constipation or chronic idiopathic constipation, announced that they have reached an agreement with Mylan NV (NASDAQ: MYL) to settle the patent litigation over the drug.

The settlement agreement provides for granting license to Mylan to market generic version of Linzess 145 mcg and 290 mcg, in the U.S., beginning Feb. 5, 2030, and generic version of Linzess 72 mcg in the U.S., beginning Aug. 5, 2030. The licensing is subject to Mylan getting the FDA go ahead for the ANDAs filed for these generics.

Ironwood and Allergan said this is the third settlement they have reached regarding the drug.

The terms of the agreement were not disclosed.

Mylan shares slipped 1.29 percent to $27.56 in after-hours trading.

Achillion Appoints Vitullo as Chair of Board

Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) announced the appointment of Nicole Vitullo, a partner at private equity firm Domain Associates, as Chair of its board, replaced David Scheer, who was serving as the Chair since 2010. The company said Scheer will remain on the board of the company.

Amphastar Launches OTC Astham Inhaler In U.S.

Amphastar Pharmaceuticals Inc (NASDAQ: AMPH) said it has commercially launched Primatene MIST, an epinephrine inhalation aerosol bronchodilator suspension, which is the only FDA-approved metered dose inhaler for asthma in the OTC market in the U.S.

The company said Primatene MIST is now available nationwide at Walgreens Boots Alliance Inc (NASDAQ: WBA) stores and online at Walgreens and CVS Health Corp (NYSE: CVS).

Merck''s Keytruda Approved For Five Additional Indications In Japan

Merck & Co., Inc. (NYSE: MRK) said it has received five new approvals for its Keytruda in Japan - as a combo treatment along with pemetrexed and platinum-based chemotherapy for first-line treatment of non-squamous non-small cell lung cancer, or NSCLC, as well as squamous NSCLC, first-line treatment of PD-L1-positive, unresectable, advanced/recurrent NSCLC, as adjuvant therapy for melanoma, and in advanced microsatellite instability-high tumors.

On The Radar

Clinical Trial Results

Sesen Bio Inc (NASDAQ: SESN) will release six-month data from a late-stage study of Vicinium, its investigational candidate for non-muscle invasive bladder cancer.

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