A roundup of developments and latest news from China (BI, BeiGene), India (Biocon), Japan (Towa Pharmaceutical, Esteve), Singapore (Tessa Therapeutics), UK (AstraZeneca), and US (Aurobindo, Bausch Health).  

China

BI Manufactures BeiGene’s Biopharmaceutical in China

Boehringer Ingelheim (BI), through its collaboration with BeiGene, a Beijing-based pharma company, has received approval from the National Medical Productions Administration of China for its new monoclonal antibody tislelizumab (BGB-A317), which is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

BI says tislelizumab is the first biopharmaceutical manufactured by a multinational contract manufacture service provider in China, which was commissioned under the new Marketing Authorization Holder (MAH) system within the revised Chinese Drug Administration Law in China. The National Medical Products Administration of China (NMPA) recently approved the new monoclonal antibody tislelizumab. The process of reforming the local MAH/contract manufacturing model to enable a new regulatory pathway for authorizing third parties to manufacture biopharmaceutical products for drug authorization holders was initiated in China in 2014. In 2015, tislelizumab, which Boehringer Ingelheim Biopharmaceuticals China manufactures became the pilot project for the new regulatory approach.

BeiGene, a global commercial-stage biopharmaceutical company focused on developing and commercializing innovative drugs for the treatment of cancer, and Boehringer Ingelheim Biopharmaceuticals China started their collaboration in 2013.  Boehringer Ingelheim’s biopharmaceutical contract manufacturing business, known as Boehringer Ingelheim BioXcellence, has been providing the chemistry, manufacturing, and control services for tislelizumab. 

Tislelizumab is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Source: Boehringer Ingelheim, BeiGene

India

Biocon To Receive $75-M Investment for Biosimilars Subsidiary

Biocon, a Bangalore, India-based pharmaceutical company, has approved a primary equity investment of Rs 536.25 Crore ($75 million) by True North, an India-based investment company into Biocon’s subsidiary, Biocon Biologics, the biosimilars business of Biocon. Under the agreement, True North will invest Rs 536.25 Crore ($75 million) that will eventually translate to a 2.44% minority stake in the biosimilars business post all restructuring, including the filed merger of Biocon Research Ltd with Biocon Biologics, valuing Biocon Biologics at Rs 21,450 Crore ($3 billion) on a pre-money equity basis. 

Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The company’s therapeutic portfolio includes products for diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. So far, the company has commercialized five biosimilars: Ogivri (trastuzumab-dkst), a breast cancer treatment; Fulphila (pegfilgrastim-jmdb), a leukocyte growth factor; Krabeva (bevacizumab) for treating several types of cancer; and rh-Insulin and Semglee (insulin glargine solution for injection 100 IU/mL in a 3-mL pre-filled pen) to control blood sugar levels, in several markets worldwide. The company has commercialized three biosimilars in the developed markets in the European Union, Australia, the US and Japan. 

The transaction is subject to standard condition precedents including regulatory approvals. Post the completion of this transaction, Biocon will hold a 96.07% stake in Biocon Biologics.

Source: Biocon

Japan

Towa Pharmaceutical to Acquire Esteve’s Generic Division for $356 M, Esteve to Acquire German Riemser

Towa Pharmaceutical, a Japanese generics pharmaceutical company, has agreed to acquire 100% ownership of Pensa Investments, the generics division of the Spanish pharmaceutical company, Esteve, for an upfront payment of EUR 320 million ($356 million).

Towa says by acquiring Pensa, it will be able to provide generic medicines not only in Japan but also abroad, by using a manufacturing factory that specializes in pellet preparation in Spain as well as its network of subsidiary companies in Europe and the United States.

In 2018, as part of its strategic plan, Esteve announced the company’s intent to focus its business on proprietary products and areas of specialized medicine. The divestiture of Pensa is a first step.

This acquisition is scheduled to be completed by the end of January 2020.

Separately, Esteve has agreed to acquire all the shares of the German pharmaceutical company Riemser from Ardian, a private investment house. Headquartered in Berlin, Riemser has a diversified portfolio of products with the three main therapeutic areas being: oncology, neurology and niche therapies. Esteve’s purchase of Riemser will accelerate its transformation into a specialty pharma company with more than 60% of its sales coming from proprietary products; it will also give Esteve access to the hospital market. The acquisition is expected to be completed within the first quarter of 2020. The parties have agreed not to disclose any details of the transaction.

Source: Towa Pharmaceutical, Esteve (Towa Acquisition), Esteve (Riemser Acquisition)

Singapore

Tessa Therapeutics to Open Cell Therapy Mfg Facility in Singapore

Tessa Therapeutics, a clinical-stage cell-therapy company in Singapore, plans to open a 90,000-square-foot commercial-scale cell-therapy manufacturing facility in Singapore by the end of 2020. Tessa has entered into a lease agreement to develop the facility within an existing high-tech industrial building in Singapore.

The new facility will be built to run both clinical and commercial manufacturing of cell-therapy products that is compliant with cGMP guidelines from the US Food and Drug Administration, European Medicines Agency and key regulators in Asia. The entire manufacturing hub, totaling 130,000 square feet, will include office space to house Tessa’s corporate headquarters

Tessa says the facility will integrate digital technology to monitor, in real-time, its manufacturing operations and vein-to-vein supply-chain logistics. The company says that the ability to digitally manage the complex process involved in delivering cell therapies to patients worldwide will enhance the traceability and control of patient material and enable greater standardization, scalability and quality management across its operations.

The new facility will also build out Tessa’s in-house process development capabilities and serve as a center of excellence to advance chemistry, manufacturing and controls development efforts of its cell therapies from early-phase clinical development through to commercialization. The company has produced and delivered autologous, personalized cell therapies to more than 100 patients in 30 clinical sites across five countries.

Source: Tessa Therapeutics

UK

AstraZeneca Divests Rights to Cancer Medicines to Juvisé Pharmaceuticals

AstraZeneca has agreed to sell commercial rights to Arimidex (anastrozole), its drug for treating early breast cancer, and Casodex (bicalutamide), for treating Stage D2 metastatic carcinoma of the prostate, in a number of European, African and other countries to Juvisé Pharmaceuticals, a France-based pharmaceutical company. The medicines, used primarily to treat breast and prostate cancers, have lost their compound patent protection in these countries. AstraZeneca previously divested the rights to both Arimidex and Casodex in the US in 2017.

As there were no closing conditions to the divestment, the agreement became effective upon signing. Juvisé Pharmaceuticals has made an upfront payment of $181 million to AstraZeneca and may also make future sales-contingent payments of up to $17 million. In 2018, Arimidex had sales of $37 million in the countries covered by this agreement, and Casodex had sales of $24 million. 

Source: AstraZeneca, Juvisé Pharmaceuticals

US

Aurobindo Pharma Issues Recall of Lot of Mirtazapine Tablets

Aurobindo Pharma USA, part of Aurobindo Pharma, a Hyderabad, India-based pharmaceutical company, has issued a voluntary recall of one lot on mirtazapine tablets, a drug for treating major depressive disorder, at the consumer level due to a label error on declared strength. Bottles labeled as mirtazapine 7.5 mg may contain 15-mg tablets.

Mirtazapine tablets are packaged in 500-count bottles. Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product.

Source: US Food and Drug Administration, Aurobindo Pharma USA

Bausch Health Acquires Novaliq’s Investigational Treatment for Dry Eye Disease

Bausch Health and Bausch + Lomb, its global eye-health business, has acquired an exclusive license from the German ocular therapeutics company Novaliq GmbH for the commercialization and development in the US and Canada of NOV03 (perfluorohexyloctane), an investigational drug with a mechanism of action to treat dry-eye disease (DED) associated with Meibomian gland dysfunction (MGD).

NOV03 is a proprietary preservative-free solution based on Novaliq’s patented water-free EyeSol technology. DED is a chronic and serious disease of the ocular surface. Under the terms of the agreement, Novaliq is eligible to receive upfront and milestone payments based on regulatory and commercialization milestones, and sales royalties based on annual net sales of NOV03 in the US and Canada.

Bausch Health has the right to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the US and Canada. Novaliq will be eligible to receive additional undisclosed milestone payments plus royalties for any resulting combination products.

Source: Bausch Health, Novaliq