Feliza Mirasol is the science editor for 

Feliza Mirasol

Alpha Teknova (Teknova), a US-based producer of critical reagents for novel therapies, vaccines, and molecular diagnostics, has opened its newest good manufacturing practice (GMP)-certified production facility in Hollister, Calif., which increases its capacity for custom, high-quality reagents for use in life sciences. The facility is expected to enable faster bioprocessing and gene therapy development, bringing products to the clinic faster, according to an Aug. 9, 2023 company press release.

The new facility, which was previously operational for research-grade production, now adds more than 10,000 ft2 of GMP-certified ISO cleanrooms. Teknova gets a three-fold increase in overall manufacturing capacity with expanded formulation, dispensing, cleanroom, and warehouse space. The facility also includes increased automation to support single-use needs and offers animal-free and endotoxin-controlled environments.

“Our team has worked tirelessly over the past two years to build our new GMP-certified production facility here in Hollister, and its opening represents a momentous milestone in our company’s evolution,” said Stephen Gunstream, Teknova’s president and CEO, in the press release. “We kept hearing from our customers that they wanted a partner who could support them with custom reagent manufacturing as they scale from research, through process development, and into clinical trials, particularly in batch volumes of less than 2000 liters. We built this facility to do just that [and] we look forward to leveraging our facility's modular manufacturing capabilities to continue supporting our customers throughout various stages of their lifecycle.”

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The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

Teknova Opens New GMP Manufacturing Facility for Life Sciences Reagents 

Eli Lilly and Company (Lilly) has announced the completion of several previously announced acquisitions: Versanis Bio (Versanis), Sigilon Therapeutics (Sigilon), and DICE Therapeutics (DICE), all of which were concluded in August 2023.

The Versanis acquisition includes that company’s lead asset, bimagrumab, a monoclonal antibody currently in Phase IIb development for treating obesity. Under the agreement, Versanis shareholders stand to receive up to $1.925 billion in cash, which includes an upfront payment and subsequent payments based on the achievement of certain development and sales milestones, according to an Aug. 14, 2023 company press release. Lilly had announced its intent to acquire Versanis Bio in July 2023 (1).

"Combining our current incretin portfolio, including tirzepatide, with activin receptor blockers such as bimagrumab, could be the next major step in innovative treatments for those living with cardiometabolic diseases, [such as] obesity," said Ruth Gimeno, group vice-president, diabetes, obesity, and cardiometabolic research, Lilly, in the company press release. "The wealth of knowledge that our new colleagues from Versanis will bring to Lilly will propel our research and development efforts forward, ultimately benefiting patients around the world."

The Sigilon acquisition, first announced by Lilly in June 2023 (2), boosts Lilly’s R&D capabilities in encapsulated cell therapies for treating type 1 diabetes and includes a lead candidate, SIG-002. According to a company press release, Lilly offered $14.92 per share of Sigilon common stock, an aggregate of approximately $34.6 million (2).

Finally, the $2.4 billion ($48 per share) DICE acquisition, 

 (3), expands Lilly's immunology portfolio. It adds DICE's novel oral therapeutic candidates for treating chronic diseases in immunology, including oral interleukin-17 (IL-17) inhibitors, to Lilly’s pipeline. The IL-17 inhibitors are currently in clinical development, according to a company press release.

1. Eli Lilly and Company, Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases. Press Release, July 14, 2023.
2. Eli Lilly and Company, Lilly to Acquire Sigilon Therapeutics. Press Release, June 29, 2023.
3. Eli Lilly and Company, Lilly to Acquire DICE Therapeutics to Advance Innovation in Immunology. Press Release, June 20, 2023.

The completion of three acquisitions of Versanis Bio, Sigilon Therapeutics, and DICE Therapeutics boosts Eli Lilly and Company’s product pipeline in obesity, diabetes, and immunology.

Lilly Completes Spate of Acquisitions

Rakuten Medical, a US-based biotechnology company specializing in cell targeting therapies, announced on Aug. 10, 2023 that it has signed an exclusive licensing and commercialization agreement with Hikma Pharmaceuticals (Hikma), a UK-based pharmaceutical company that serves the Middle East and North Africa (MENA) region as well as Europe.

Under the agreement, Hikma gains an exclusive license to commercialize products in Rakuten Medical’s oncology pipeline to all of Hikma’s MENA markets. Rakuten Medical’s oncology pipeline was developed using its proprietary photoimmunotherapy technology platform, Alluminox. These therapies are not currently approved in MENA for investigational or commercial use. Outside of Japan, they are investigational treatments, according to a company press release.

“We are already developing Alluminox treatment in several countries and regions, including the United States, Japan, Taiwan, and India, and this agreement further accelerates our global expansion. With Hikma’s strong regional footprint and medical expertise, we expect the Alluminox platform to make significant progress in MENA,” said Mickey Mikitani, co-CEO of Rakuten Medical, in the company press release.

“This agreement allows us to work with an excellent global partner to strengthen our growing portfolio in oncology and biotechnology. Most importantly, this allows us to bring a potentially transformative technology to cancer patients in MENA, helping to put better health within reach, everyday,” said Mazen Darwazah, executive vice-chairman and president of MENA, Hikma, in the release.

Under the exclusive agreement, Hikma will commercialize products in Rakuten Medical’s pipeline for cancer treatment in the Middle East and North Africa region.

Rakuten Medical Signs Exclusive Licensing Agreement with Hikma for Cancer Treatments in MENA

On July 24, 2023, Teva Pharmaceuticals, Inc., a US-based affiliate of Teva Pharmaceutical Industries, and Alvotech, an Iceland-based biotech company specializing in biosimilars, announced that they are expanding an existing strategic partnership for the development and commercialization of several biosimilar candidates. Under the expanded agreement, Teva will also acquire subordinated convertible bonds—to be issued by Alvotech—for $40 million.

With the expanded agreement, Teva will have exclusive commercialization rights in the United States for two new biosimilar candidates and line extensions of two current biosimilar candidates. Alvotech will be responsible for the development and manufacturing of these four candidates. The agreement includes milestone payments, the majority of which will be paid upon approval of the products and upon achieving significant sales milestones. Teva and Alvotech will share the profit from the commercialization of the biosimilars.

In addition, Teva will be involved in overseeing manufacturing activities and quality control at Alvotech’s manufacturing facility in Iceland. Teva is on site in Iceland to actively support Alvotech and to help ensure that the facility is fully ready for an FDA inspection, according to a company press release.

Meanwhile, the partners will continue to work closely on the pending US approval of AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). Under the existing partnership, the companies are also collaborating on four other biosimilar candidates, including AVT04, a proposed biosimilar for Stelara (ustekinumab), which is currently pending FDA approval. Furthermore, Teva’s investment under the expanded agreement (i.e., the acquisition of subordinated convertible bonds) will be used by Alvotech to fund the continued development of its biosimilars pipeline in the near-term.

“We welcome Teva’s continued partnership, and this expansion of our partnership agreement,” said Robert Wessman, chairman and CEO of Alvotech, in the press release. “We remain focused on preparing for a successful pre-approval inspection and resolving any outstanding issues identified by [FDA] to be able to bring our biosimilar candidates to patients in the US with Teva as soon as possible.”

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Teva Pharmaceuticals and Alvotech Expand Existing Biosimilars Partnership

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on July 21, 2023 that they have received a positive opinion for two novel bispecific antibodies from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP has recommended conditional marketing authorization for TALVEY (talquetamab) and has recommended the approval of a Type II variation for teclistamab (marketed under the brand name TECVAYLI).

Janssen is seeking approval of talquetamab as a monotherapy to treat adult patients with relapsed and refractory multiple myeloma (RRMM). The indication is for RRMM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, but who have still demonstrated disease progression on the last therapy. Talquetamab, a subcutaneous bispecific antibody, binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells, according to a company press release.

The CHMP’s recommendation for the Type II variation for teclistamab means that, if approved, then the dosing schedule for the therapy can be reduced to a biweekly dosing schedule in patients who have achieved a complete response or better for six months or longer. Teclistamab is a bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells. According to the company press release, it is the first bispecific antibody with this mechanism of action to be licensed in Europe for treating adult RRMM patients who have had at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who have demonstrated disease progression on the last therapy.

“With talquetamab, a novel bispecific antibody targeting GPRC5D, we look to … bring forward a vital new treatment option for patients with relapsed and refractory multiple myeloma, who have a poor prognosis,” said Edmond Chan, senior director EMEA Therapeutic Area Lead Hematology, Janssen-Cilag, in the press release. “Today’s recommendation from the CHMP marks an exciting step for patients who continue to face the challenges of this difficult-to-treat blood cancer. We look forward to working with health authorities to bring talquetamab to patients in need across the region as soon as possible, while we continue our focus on enhancing a robust multiple myeloma portfolio of therapeutics and regimens.”

“Pending approval, this variation for teclistamab will be an important step forward for this first BCMA bispecific therapy, offering flexible, less frequent dosing depending on a patient’s response,” said Sen Zhuang, vice president, Clinical Research and Development, Janssen Research & Development, in the release.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt Germany, has invested $25 million to expand its cell culture media production facility in Lenexa, Kan. With the investment, the company intends to add 98,000 ft2 of lab space and cell culture media production capability, the company announced in a July 12, 2023 press release.

Counting its Lenexa site, the company has a total of three centers of excellence for dry powder cell culture media manufacturing. The other two centers are in Nantong, China, serving the Asia Pacific region, and Irvine, Scotland, serving Europe, the Middle East, and Africa region.

“This expansion makes Lenexa the company’s largest dry powder cell culture media facility and [c]enter of [e]xcellence in North America,” said Darren Verlenden, head of Process Solutions, Life Science, MilliporeSigma, in the press release. “Investing in the region reflects our strategy to expand and diversify our supply chain to ensure we meet current and future demand for cell culture media.”

“The new production line represents the company’s vision for our Lenexa site, as it was initially constructed for three manufacturing lines for dry powder cell culture media,” Verlenden said in the release. “The new production line is the culmination of multiple years of planning, and now we are able to offer greater flexibility and faster cell culture media manufacturing for our customers.”

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.