Scrip: industry news and insights
By John Davis 28 Feb 2020
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies...
Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Strategic Transactions.
The Indian vaccine maker Bharat Biotech International Ltd. has acquired Chiron Behring Vaccines Pvt Ltd. from GlaxoSmithKline Asia, bringing into its fold Chiron’s established local rabies vaccine operations.
While details of the transaction announced Feb. 15 are still sketchy, Bharat expects to build on Chiron’s manufacturing capabilities and expand international reach of the rabies vaccine, which is manufactured at Ankleshwar, in the western Indian state of Gujarat. The all-cash deal is subject to certain closing conditions, which Bharat and GSK say they expect to complete in the next few weeks.
Chiron Behring is a WHO pre-qualified manufacturer of rabies vaccines, eligible for supplies to UN agencies with product registrations in more than 20 countries. Bharat now expects to expand market access through product registrations in additional high-demand countries. Rabies is a vaccine-preventable disease estimated to claim over 55,000 lives each year, mostly in Asia and Africa. About 36% of the world’s rabies deaths occur in India.
Chiron Behring Vaccines, which has a long history in India and has changed hands multiple times, was formed as a result of the purchase of the vaccines business of Hoechst AG by Chiron Corporation US.[See Deal] In 2005, Chiron announced a merger with Novartis AG globally, after which Chiron Behring Vaccines Pvt Ltd India, a 51/49 joint venture between Chiron and Aventis Pharma Ltd., became part of the Novartis fold.[See Deal]
In 2010, Aventis Pharma exited the rabies vaccine joint venture, divesting its 49% holding in Chiron Behring to Novartis for about $22.4m. (Also see "Aventis to exit rabies vaccine JV with Novartis in India" - Scrip, 13 Dec, 2010.) Then in 2014, globally Novartis and GlaxoSmithKline PLC entered into a multi-part transaction under which Novartis divested its vaccines business to GSK, while GSK transferred its oncology products to Novartis; the two companies, at the time, also announced plans to combine their over-the-counter and consumer health care businesses in a joint venture.[See Deal] This deal brought Chiron Behring in India under the GSK umbrella.
In 2016, GSK Pharmaceuticals India managing director Annaswamy Vaidheesh toldScripthat the Novartis rabies vaccines (marketed asRabipur) had great brand equity and was an “excellent fit” for the GSK portfolio with a larger vaccine-dedicated field force. The vaccine is also exported to China from the Indian facility, he said at the time. (Also see "Interview: GSK India's Playbook For Vaccines Dominance" - Scrip, 24 Aug, 2016.) The Rabipur brand name is unlikely to be part of the deal with Bharat, although there is no official word on this. With a portfolio of over 15 products, Bharat already has its own rabies vaccine brand Indirab. (Also see "Bharat Biotech Gets WHO Nod For ‘Game-Changer’ Typhoid Vaccine" - Scrip, 10 Jan, 2018.)
STA Pharmaceutical Co. Ltd.,a subsidiary of Chinese contract services giant WuXi AppTec Inc., and Swiss company BioLingus announced on Feb. 18 they had formed an exclusive technology and marketing collaboration for sublingual delivery. Financial details were not disclosed.
Under the deal, WuXi STA obtains exclusive access to BioLingus’ technology for sublingual and buccal delivery in the contract development and manufacturing organization. BioLingus has developed a novel proprietary platform to stabilize and deliver sublingually a variety of drug targets including small molecules, peptides, proteins and vaccines that are currently administered via injection.
In 2017, WuXi STA merged with WuXi AppTec’s Pharmaceutical Development Services unit to better integrate the chemistry, manufacturing and controls (CMC) supply chain. Over the past year, two new commercial drug facilities, in Shanghai and Wuxi city, Jiangsu province, have also come into operation, enabling WuXi STA to support solid-dosage drug development from the preclinical to commercial stage.
Ascletis Pharma Inc.licensed exclusive rights Feb. 12 to develop, manufacture and sell in Greater China 3-V Biosciences Inc.’s Phase II-ready fatty acid synthase inhibitor TVB2640 for non-alcoholic steatohepatitis (NASH). Under terms of the deal, 3-V is eligible for development and sales milestones, plus royalties. Concurrently, Ascletis led 3-V’s $18m Series E round.[See Deal]
TVB2640 (which Ascletis has renamed ASC40) is an orally bioavailable inhibitor of fatty acid synthase (FASN), an enzyme in the de novo lipogenesis pathway that catalyzes the biosynthesis of palmitate; dysregulation of FASN is found in multiple liver diseases as well as cancer.
The deal is the second in-licensing for Ascletis this year. In January, it gained exclusive rights in China, Hong Kong, Macao, and Taiwan to Alphamab’s KN035 (renamed ASC22) for viral diseases including hepatitis B.[See Deal]
WuXi Biologics and ABL Bio Corp. announced on Feb. 26 that they will expand their strategic partnership for novel bispecific antibodies and immuno-oncology. Under the agreements, ABL obtains rights to use WuXi Biologics’ proprietary discovery platforms, includingWuXiBodyand the CD3 platform, to research, develop and commercialize multiple bispecific antibodies, as well as rights to develop new bispecific antibodies targeting novel immune checkpoint receptors.
WuXiBody, a proprietary bispecific antibody platform of WuXi Biologics, is potentially the best-in-class bispecific platform in the field. It can effectively break through the CMC barriers of bispecific antibodies development, expedite the process by six to 18 months and significantly reduce manufacturing cost, a severe limitation of other current bispecific platforms.
WuXi Biologics will receive an upfront payment as well as development, regulatory and commercial milestone payments of about $220m, and be entitled to royalties based on global sales of these programs.
In November 2018, ABL and WuXi Biologics reached an exclusive development and clinical manufacturing partnership for multiple bispecific antibodies. The latest deal further strengthens the collaboration.
Daewon Pharmaceutical Co. Ltd. said on Feb. 26 that it has licensed Tium Bio Co. Ltd.’s TU2670, a novel, next-generation therapeutic for endometriosis and uterine fibroids. Under the agreement, Daewon gets exclusive rights to develop, manufacture and commercialize the novel oral drug candidate in South Korea. Financial terms weren’t disclosed.
TU2670, a GnRH antagonist, has improved administration convenience versus existing drugs which have injection formulation. It has completed a Phase Ia trial in South Korea and is targeted for launch in 2025.
Daewon said the global endometriosis treatment market is growing steadily and is estimated to exceed $3bn in 2027. Once the drug is launched, the South Korean pharma plans to add indications such as precocious puberty and seek exports of the drug.
Aslan Pharmaceuticals Pte. Ltd.announced on Feb. 27 that it had granted South Korean firm BioGenetics exclusive rights to commercialize the cancer drug varlitinib in all indications in South Korea, in exchange for an upfront payment of $2m and up to $11m in sales and development milestones.
ASLAN is also eligible to receive tiered double-digit royalties on net sales up to the mid-20s, and will continue to fund all clinical development of varlitinib, an oral, reversible small molecule pan-HER inhibitor. BioGenetics will be responsible for obtaining initial and all subsequent regulatory approvals of the drug in South Korea.
ASLAN is currently conducting the TreeTopp global pivotal trial in second-line biliary tract cancer (BTC), with top-line data expected in the second half of 2019, and recently presented positive data from an ongoing Phase Ib/II trial of varlitinib plus gemcitabine and cisplatin in first-line BTC. The molecule has already been awarded orphan drug designation for BTC in South Korea, which extends the marketing exclusivity period and waives certain local clinical trial requirements.
JooHoon Ahn, CEO of Biopharma at BioGenetics, said that the company is “excited by the clinical data in BTC that ASLAN has generated to date. The unmet need for effective treatments for BTC, one of the ten most prevalent cancers in South Korea, is high.”
In 2015, ASLAN had entered into an agreement with another Korean firm,Hyundai Pharm Co. Ltd., to develop and commercialize varlitinib for cholangiocarcinoma in the country.[See Deal] Prior to executing a broader agreement with BioGenetics, ASLAN exercised its right to buy back rights in this indication, paying $300,000 to Hyundai.
BioGenetics, formerly Unidus Corp., manufactures medical products and established a biopharmaceutical division in April 2018 under Ahn, who was most recently senior managing director at Kwangdong Pharmaceutical Co. Ltd. Biogenetics is also co-developing WM-S1-001 for cetuximab-resistant colon cancer with WellMarkerBio, a spin-off company from Korea’s Asan Medical Center.
Stay tuned for the next issue of Deal Watch. You can read more about other deals that have been covered in depth by Scrip in recent days below:
(Also see "Tough Going Forces Chinese Biotechs To Form Domestic Alliances" - Scrip, 20 Feb, 2019.)
Deals among domestic Chinese biotechs are growing fast, reflecting a need to huddle up amid tightening scrutiny over biotech deal-making and an unusually competitive immuno-oncology market.
(Also see "Cipla Backs Start-Up As It Builds Digital Health Strategy" - Scrip, 19 Feb, 2019.)
Cipla Ltd.has picked up a minority holding in the Indian digital therapeutics firm Wellthy, and the duo will combine forces to improve patient outcomes in specific chronic therapies.
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