BHVN In Focus, Fresenius Calls Off Deal To Buy AKRX, Good News For GUD

(RTTNews) - Today's Daily Dose brings you news about Fresenius Kabi walking out of the Akorn deal; settlement of the long-running trade secret misappropriation suit between Alnylam) and Dicerna; Abeona's gene therapy program ABO-202 for the treatment of Batten Disease securing Orphan Drug Designation in the European Union; Biogen and Ionis expanding their strategic collaboration, and review of new data from Biohaven's two pivotal phase III trials of Rimegepant in acute treatment of migraine.

Read on…

German pharmaceutical firm Fresenius Kabi, which had inked an agreement to acquire Akorn Inc (AKRX) for US$34 per share, equivalent to a total acquisition price US$4.3 billion, plus approximately US$450 million of net debt, last April, has now pulled out of the deal.

The acquisition was supposed to close in early 2018. But in February of this year, Akorn came under scrutiny for possible violations of FDA data integrity rules. Since then, speculation has been rife about the consummation of the transaction.

On February 26, 2018, Fresenius revealed that it is conducting an independent investigation, using external experts, into alleged breaches of FDA data integrity requirements relating to product development at Akorn.

Now, the German drugmaker has decided to terminate the merger agreement, saying that Akorn has failed to fulfill several closing conditions.

Commenting on Fresenius Kabi's decision, Akorn said, "We categorically disagree with Fresenius' accusations. The previously disclosed ongoing investigation, which is not a condition to closing, has not found any facts that would result in a material adverse effect on Akorn's business and therefore there is no basis to terminate the transaction. We intend to vigorously enforce our rights, and Fresenius' obligations, under our binding merger agreement".

AKRX closed Friday's trading at $19.70, up 1.65%.

Abeona Therapeutics Inc.'s (ABEO) gene therapy program ABO-202 for the treatment of subjects with neuronal ceroid lipofuscinosis, also known as Batten Disease, has been granted Orphan Drug Designation in the European Union.

ABO-202 for Infantile Batten Disease is expected to enter clinical trials this year.

The compound has already secured Orphan Drug and Rare Pediatric Disease Designations from the FDA.

ABEO closed Friday's trading at $20.90, up 4.24%.

Atossa Genetics Inc. (ATOS) announced a 1-for-12 reverse split of its common stock effective April 20, 2018.

As a result of the reverse split, the number of outstanding common shares will be reduced from approximately 31.8 million shares to approximately 2.65 million shares.

ATOS closed Friday's trading at $3.52, down 19.35%.

Biohaven Pharmaceutical Holding Co. Ltd. (BHVN) on Saturday announced that durability of clinical effect of Rimegepant in acute treatment of migraine was seen across multiple outcome measures in two pivotal phase III trials, and that the findings were consistent across both the studies.

On March 26, 2018, Biohaven Pharma announced positive top-line results from its two phase III clinical trials of Rimegepant - with each trial meeting the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom.

According to the new data, a durable effect with Rimegepant was achieved with pain freedom lasting up to 48 hours following a single dose. About 90% of patients who took Rimegepant and no rescue medications achieved the clinically important endpoint of pain relief within 8 hours. Pain relief was sustained throughout 48 hours.

More than 3x the number of subjects who responded to treatment preferred Rimegepant over their previous therapy, noted the Company.

Richard Lipton, Vice Chair of Neurology, Professor of Epidemiology and Population Health and Director of the Montefiore Headache Center, at the Albert Einstein College of Medicine, and Chair of Biohaven's CGRP Scientific Advisory Board added, "The single dose data from these two clinical trials are very exciting as Rimegepant brings forward a novel mechanism of action that has demonstrated important clinical benefit to patients. Most of the patients I see with migraine are actively working and raising children, and relieving pain and restoring function means they can once again take care of their families and return to work. The new data reviewed today encourages me that Rimegepant, if approved, can meet their needs for an acute treatment with lasting clinical benefit."

BHVN closed Friday's trading at $27.18, down 0.33%.

Biogen (BIIB) and Ionis Pharmaceuticals (IONS) have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases.

Under the new deal, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an approximately 25% cash premium, and a $375 million upfront payment.

Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization. In addition, Biogen may pay milestone payments, license fees and royalties on net sales.

The new expanded deal builds upon the productive collaboration inked in January 2012 that produced SPINRAZA as well as two antisense drug candidates currently in the clinic, with the potential to advance up to seven more drug candidates to the clinic within the next two years.

Spinraza, developed under the Biogen and Ionis collaboration, was approved by the FDA in December 2016, to treat children and adults with spinal muscular atrophy (SMA).

IONS closed Friday's trading at $48.51, up 5.80%.

Clementia Pharmaceuticals Inc. (CMTA) has initiated its phase II study of Palovarotene for the treatment of pediatric patients with multiple osteochondromas (MO), also known as multiple hereditary exostoses (MHE).

The study, dubbed MO-Ped Trial, will enroll 240 patients ranging in age from 2 to 14 years old at approximately 29 centers in 12 countries around the world. Patients enrolled will be randomized into one of three arms to receive a weight adjusted equivalent of 2.5 mg or 5.0 mg of Palovarotene daily, or placebo.

The Company expects the 12-month interim data readout to be in the first half of 2020, with 24-month top-line results from the study in the first half of 2021.

CMTA closed Friday's trading at $17.63, down 9.31%.

The trade secret misappropriation suit between Alnylam Pharmaceuticals Inc. (ALNY) and Dicerna Pharmaceuticals Inc. (DRNA) has finally come to an end.

The lawsuit, filed in June 2015, involves Alnylam's proprietary, and trade secret information related to, among other things, GalNAc conjugate technology.

Under the terms of the agreement, Dicerna will pay $25 million comprised of cash and stock to Alnylam, and Dicerna will be restricted in its development and other activities relating to oligonucleotide-based therapeutics directed toward a defined set of Alnylam targets, for periods ranging from 18 months up to four years.

The settlement does not include any license to Alnylam's GalNAc conjugate intellectual property (IP) or any licenses to any other IP from either party. Nor does the settlement include any admission of liability or wrongdoing by either company. All other settlement terms are confidential, Anlylam revealed.

DRNA closed Friday's trading at $12.01, up 17.86%.

Knight Therapeutics Inc. (GUD.TO) on Friday announced that PROBUPHINE, a subdermal implant designed to deliver buprenorphine for the management of opioid drug dependence, has received regulatory approval in Canada.

Knight received the exclusive rights from Braeburn Pharmaceuticals Inc. in February 2016 to commercialize PROBUPHINE in Canada.

Braeburn obtained the FDA approval for PROBUPHINE in May 2016.

GUD.TO closed Friday's trading at C$7.79, up 0.13%.

QIAGEN N.V.'s (QGEN) PartoSure, a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor, has received FDA approval.

PartoSure is already being used in more than 35 countries across Europe, the Middle East, Asia and Latin America.

PartoSure is expected to be commercialized in the U.S. in 2018.

QGEN closed Friday's trading at $32.81, up 0.06%.

Summit Therapeutics plc's (SMMT) new 24-week interim analyses from its PhaseOut DMD trial shows correlation between decreases in muscle damage and reduction in muscle inflammation in patients treated with Ezutromid.

The PhaseOut DMD study is a phase II trial evaluating Ezutromid in Duchenne muscular dystrophy.

The Company announced positive 24-week interim data from the PhaseOut DMD trial in January of this year. Top-line 48-week data from the PhaseOut DMD trial is expected to be reported in Q3, 2018.

SMMT closed Friday's trading at $13.88, up 0.95%.