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Laboratory Focus May/June 2015
Pharma Notes Resverlogix Corp. (Calgary, AB) reports it has entered into an agreement with Shenzhen Hepalink Pharmaceutical Co., Ltd. (Hepalink) for an equity investment and a license of its lead product RVX-208, for all indications in China, Hong Kong, Taiwan and Macau markets. Under the terms of the transaction, Hepalink will subscribe for 13,270,000 Resverlogix common shares and 1,000,000 common share purchase warrants, for aggregate proceeds of approximately C$35 million. Hepalink will also be entitled to nominate one mutually agreed representative for election to the board of directors of the company. Aeterna Zentaris Inc. has filed an application for a patent (European Patent Office priority application: EP15000132) on a method of manufacturing zoptarelin doxorubicin. The hybrid cytotoxic molecule is the subject of a pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 clinical study in women with advanced, recurrent or metastatic endometrial cancer. The molecule combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is a Luteinizing Hormone Releasing Hormone (LHRH) agonist, a modified natural hormone with affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumours. Potential benefits of this targeted approach include a better efficacy and a more favourable safety profile with lower incidence and severity of side effects as compared to doxorubicin alone. The patent application, which is entitled “Enzymatic process for the regioselective manufacturing of NFmoc-doxorubicin-14-O-dicarboxylic acid mono esters,” may, if granted, make it difficult for generic manufacturers to produce the compound on a financially feasible basis after the company’s composition-of-matter patent on zoptarelin doxorubicin expires. Transition Therapeutics Inc. (Toronto, ON) through its whollyowned subsidiary, Transition Therapeutics Ireland Limited has exclusively licensed the worldwide rights to a novel small molecule drug candidate (TT701) from Eli Lilly and Company. The molecule, TT701, is a selective androgen receptor modulator that has been shown in a Phase 2 study to significantly increase lean
body mass and a measurement of muscle strength in male subjects. This Phase 2 study of 350 subjects also demonstrated additional beneficial effects, including significant fat mass reduction with no significant change in prostate specific antigen (PSA) levels. Transition is evaluating multiple development paths for TT701, including as a new therapeutic option for patients with androgen deficiency. Under the terms of the agreement, Lilly will receive a contingent upfront consideration of up to US$1 million. In addition, Lilly is eligible to receive up to US$100 million in commercial milestones and a mid-single digit royalty on sales of TT701 products should such products be successfully commercialized. Privately held biotechnology company Northern Biologics Inc. reports it is collaborating with Celgene Corporation. As part of the collaboration, Northern Biologics has received a US$30 million upfront cash payment. It will use the funds to discover and develop first-in-class therapeutic antibodies in oncology and fibrosis from preclinical discovery through human clinical trials. Northern Biologics will also have the right to receive additional future payments that support the advancement of its portfolio. In return, Celgene will have options to in-license drug candidates and acquire Northern Biologics upon conclusion of the collaboration. Northern Biologics was launched in June 2014 by Blueline Bioscience, a Canadian biotechnology incubator backed by venture capital firm Versant Ventures, in partnership with the University of Toronto and University Health Network’s Princess Margaret Cancer Centre. Versant committed a US$10M Series A financing round to Northern Biologics in October 2014. Cyclenium Pharma Inc. and Haplogen GmbH have signed a research agreement aimed at the discovery of novel pharmaceutical candidates in multiple disease areas. The collaboration brings together two next generation drug discovery platforms: Cyclenium’s CMRT™ Technology-derived QUEST Library™ and associated hit-tolead optimization expertise with Haplogen’s unique haploid genetics technology and expertise in host target identification, validation and screening. The companies will initially focus on certain anti-viral Haplogen targets, with targets in other therapeutic indications being
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phased-in as the research progresses. For Cyclenium, this is the fifth discovery collaboration established over the past year.
by the center, MUSC shall pay the company a royalty on net sales of all commercialized products developed from the candidate.
Cipher Pharmaceuticals Inc. (Mississauga, ON) reports it has expanded its Canadian dermatology portfolio acquiring the Canadian rights to Vaniqa® and Actikerall® from Almirall S. A., a Spanish pharmaceutical company. Both products have been approved by Health Canada. VANIQA is a prescription cream clinically proven to reduce the growth of unwanted facial hair in women. VANIQA cream is an enzyme inhibitor and works by blocking an enzyme necessary for hair to grow. The product was approved by Health Canada in May, 2001. Actikerall is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis, a pre-cancerous patch of thick, scaly, or crusty skin. The product was approved by Health Canada on July 31, 2014 and will be launched by Cipher in the first half of 2015. Under the terms of the agreement, Almirall will receive an upfront payment of CDN$0.45 million and is eligible for certain milestones from product sales in Canada. Almirall will supply the finished product to Cipher.
STEMCELL Technologies Inc. has signed a license agreement with the Salk Institute for Biological Sciences for the rights to commercialize BrainPhys™ Neuronal Medium. Invented by Cedric Bardy in the lab of neuroscientist Fred H. Gage, this formulation promotes optimal neuronal and synaptic activity while supporting long-term culture of both human pluripotent stem cell (hPSC)derived neurons and primary tissue-derived neurons. BrainPhys™ Neuronal Medium will complement STEMCELL’s portfolio of products for neural cell culture applications, including the NeuroCult™ product line for tissue-derived neural cells, and the STEMdiff™ Neural System for hPSC-derived neural cells.
Aeterna Zentaris Inc. (Quebec City, QC) announces that it has agreed to transfer its discovery library of roughly 100,000 unique compounds to the South Carolina Center for Therapeutic Discovery & Development pursuant to a just concluded Material Transfer Agreement. The library will be used to discover drug development candidates for the company in the areas of oncology, neurology, endocrinology and women’s health. The center has agreed to conduct screening and pre-clinical activities with respect to the library and will submit to the company at least one development candidate in its areas of therapeutic interest per year during a ten-year period beginning in 2018. The company will receive the right of first refusal to license the development candidates. Should the company decide to further develop a candidate submitted by the center, MUSC will license the compound to the company, and be entitled to a royalty on the net sales of all commercialized products developed from the development candidate. However, should the company decide not to further develop the development candidate submitted
OncoGenex Pharmaceuticals, Inc. announced that its wholly owned subsidiary, OncoGenex Technologies Inc., has executed a termination agreement with Teva Pharmaceuticals Ltd. under which OncoGenex will regain rights to custirsen, an investigational compound currently in Phase 3 clinical development as a treatment for prostate and lung cancers. This transfer of rights occurs in connection with the termination of the 2009 collaboration agreement between OncoGenex and Teva. The agreement between the two parties to terminate the collaboration includes a $23.2 million payment from Teva. The Fight Against Cancer Innovation Trust and its partners announce the formation of Turnstone Biologics Inc., a biotechnology company focussed on developing treatments for cancer that harness the patient’s own immune system. The company represents a unique collaboration between the Children’s Hospital of Eastern Ontario (CHEO) Research Institute, McMaster University, the Ontario Institute for Cancer Research (OICR), the Ottawa Hospital Research Institute, the University of Ottawa and FACIT. The new company hopes to accelerate clinical translation and commercialization of oncolytic vaccine immunotherapies for the treatment of cancers. Turnstone’s lead technology platform, Marabex™, combines the benefits of oncolytic viral therapy with a tumour-targeted vaccine into a single treatment.
