D-Pharm announces positive phase 2 study results of THR-18 in acute stroke patients

D-Pharm Ltd., a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders, has received the final report for its phase 2 clinical study of THR-18. THR-18 demonstrated statistically significant reductions in the incidence of intracranial hemorrhage (ICH), brain swelling (edema) and a satisfactory safety profile in stroke patients treated with tPA. Moreover, stroke recovery was improved 2-fold in patients receiving THR-18, as judged by clinical outcome measures, 30 days following stroke.

THR-18 is a novel drug-candidate designed to neutralize or reduce the life-threatening adverse effects of thrombolytic therapy with tPA. This double-blind, placebo-controlled, escalating single-dose, Phase 2 study was the first to assess the safety, pharmacodynamics and pharmacokinetics of THR-18 and tPA in AIS patients. The study results were presented last month at the European Stroke Organization conference in Glasgow.

The study successfully defined the maximal tolerated and safe dose of THR-18 in AIS patients. The imaging data as assessed by CT (computed tomography) on day 2 following stroke and tPA treatment indicate that, in contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage, (p=0.02). Similarly, 0.54 mg/kg of THR-18 reduced by more than twice the occurrence of brain edema (p<0.05). 

Vanda Pharma receives US patent for Fanapt

Vanda Pharmaceuticals Inc. (Vanda),  a biopharmaceutical company, announced that a Fanapt patent, number 8,999,638 ('638 patent), is now listed in the US Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book.  The '638 patent was issued by the United States Patent and Trademark Office on April 7, 2015 and expires in October 2030.

Prior to this newly listed '638 patent, the Fanapt Orange Book listed patents were the US composition of matter patent and the '610 patent, expected to expire in November 2016 and November 2027, respectively.

Nanolek to commercialise Green Cross' biologics in Russian market

South Korean biopharmaceutical company, Green Cross and Nanolek, a Russian pharmaceutical company, have entered into a strategic partnership agreement for the commercialisation of Green Cross' biologics in the Russian market.

Under the terms of the agreement, Nanolek will obtain marketing authorisations and set up the production of a number of Green Cross' biologics. The production will be organised at Nanolek's facility, a state-of-art biopharmaceutical complex built and equipped in compliance with EU GMP standards and launched in December 2014.

"This partnership is a perfect strategic fit for Green Cross' global business model," said EC Huh,  president of Green Cross Corporation. "We are excited to work with the team at Nanolek, and to share in the longer-term commercial success of Green Cross' products as it enters Russia."

"Our project with Green Cross will make socially significant drugs more accessible and minimize the state's financial burden for the procurement of these drugs outside of Russia," said Mikhail Nekrasov, CEO of Nanolek. "Making possible the domestic production of a number of biopharmaceuticals is our contribution to the implementation of the government policy in developing the Russian pharmaceutical industry."

Russia's pharmaceutical market is one of the most attractive in the emerging European region, mainly due to its absolute size, plus a growing economy and increasing government investment in healthcare, according to a report from Business Monitor International. The Russian market is set to grow at twice the pace of the global pharmaceutical market, with growth estimates around 10-15% annually reaching an approximate market value of $43-60 billion by 2020.

MerLion annnounces positive results from phase 2 trial with inafloxacin

MerLion Pharmaceuticals, a biopharmaceutical company based in Singapore and Berlin, announced positive results from a phase 2 trial with finafloxacin, conducted in Europe, treating patients hospitalised with complicated urinary tract infections (cUTI), including a high proportion with pyelonephritis.

Finafloxacin is a fluoroquinolone antibiotic that demonstrates a substantially improved therapeutic profile over the existing gold standard and greater utility in treating many severe infections, including those caused by a number of resistant Gram-negative pathogens. This superior profile is a result of finafloxacin’s unique chemical structure: in the hostile acidic conditions found at the sites of nearly all infections there is a substantially higher take-up and accumulation of finafloxacin in bacterial cells, as well as superior binding of the molecule to the two fluoroquinolone targets. Most other antibiotics, including other fluoroquinolones, have decreased activity in these acidic conditions where their effectiveness is most needed.

The results from this phase 2 study indicate that patients treated with a five day course of finafloxacin had a higher, more rapid and more sustained level of microbiological eradication and improved clinical outcomes than those treated with the current standard of care (ciprofloxacin taken twice daily for 10 days). The trial’s primary and secondary endpoints were all successfully achieved. Finafloxacin was found to be both safe and tolerable, with only a small number of class-typical adverse events observed.

Aeterna Zentaris, ASCEND ink co-promotion pact for US market

Aeterna Zentaris Inc.,  a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology, announced a strategic co-promotion services agreement with ASCEND Therapeutics US, LLC, (ASCEND), a specialty pharmaceutical company solely focused on women's healthcare.

Under the terms of the agreement, expected to start in the fourth quarter of 2014, Aeterna Zentaris will use its newly established commercial structure to market, in specific US territories, ASCEND's EstroGel a non-patch transdermal US Food & Drug Administration (FDA) approved and commercialized estrogen replacement therapy. For its part, ASCEND would market, in specific US territories, Macrilen, Aeterna Zentaris' product for use in the evaluation of adult growth-hormone deficiency (AGHD), for which a New Drug Application (NDA) is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of November 5, 2014. In consideration for these co-promotion services, each party will be entitled to receive, from the other party, commissions on net sales of each other's product.

ANI Pharma buys US rights for Vancocin capsules from Shire

ANI Pharmaceuticals, an integrated specialty pharmaceutical company, has acquired the US rights for Vancocin 125 mg and 250 mg capsules from Shire plc, a global biopharmaceutical company.

In addition, ANI acquired from Shire approved ANDAs for the currently non-marketed products vancomycin hydrochloride injectable 500 mg, 1 gm and 10 gm ($45 million in 2013 market value, per IMS Health) and vancomycin hydrochloride oral solution 250 mg and 500 mg. ANI paid $11 million in cash for the rights to Vancocin together with existing inventories on hand. Following a transition period, ANI intends to launch Vancocin capsules under its own label during the fourth quarter of 2014. The transaction is immediately accretive and sales of Vancocin capsules are expected to generate approximately $5.4 million in revenues and $4 million in non-GAAP EBITDA annually.

Arthur S. Przybyl, ANI’s president and chief executive officer, stated, “We are excited to add Vancocin capsules to our portfolio of mature brand products. In addition, we will immediately begin exploring opportunities to launch both vancomycin injectable and vancomycin oral solution. Year to date we have invested $23 million in two mature brand acquisitions that will contribute a combined $9.4 million in annual revenues and $8 million in annual non-GAAP EBITDA. At the same time, we are continuing to advance our internal generic product development pipeline while selectively pursuing acquisitions and partnerships that augment those efforts.

OPKO

Opko Health, Inc., a multi-national biopharmaceutical and diagnostics company, announced that Senesco Technologies, Inc. (Senesco), completed its acquisition of Fabrus, Inc. (Fabrus), an Opko portfolio company focused on expanding the clinical impact of antibodies by addressing drug targets resistant to traditional antibody discovery methods.

Fabrus has been successful in generating antibodies against difficult, therapeutically important cell surface receptors and ion channels resulting in an internal pipeline that includes next generation antibodies targeting cancer and inflammation. It also has collaborations in place with large pharma and biotech companies to discover antibodies to their targets. Dr Vaughn V Smider, founder of Fabrus and faculty member at The Scripps Research Institute in La Jolla, CA, will become acting CEO of Senesco.




In the short term, the business focus of the combined company will be to realize the synergies of the combination, advancing the SNS01-T clinical program and bringing new candidates into clinical development in the next two years.