On September 29, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616)] and Pfizer Investment Co. Ltd. ("Pfizer Investment") and Pfizer Corporation Hong Kong Limited ("Pfizer Hong Kong") (both of which are subsidiaries of Pfizer Inc. (NYSE: PFE)) reported the formation of a strategic collaboration that encompasses a $200 million equity investment by Pfizer Hong Kong in CStone, collaboration between CStone and Pfizer Investment for the development and commercialization of CStone’s sugemalimab (CS1001, PD-L1 antibody) in mainland China, and a framework between CStone and Pfizer Investment to bring additional oncology assets to the Greater China market (Press release, CStone Pharmaceauticals, SEP 29, 2020, View Source [SID1234567760]).

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This collaboration provides financing to support CStone’s development of sugemalimab, a potential best-in-class PD-L1 antibody that is being developed for high-incidence cancer indications in China, including lung, gastric and esophageal cancers, among others. Pfizer will in-license and exclusively lead commercialization of sugemalimab in China, harnessing its industry-leading capabilities to help doctors and patients across a far wider range of regions gain greater access to this treatment. The collaboration positions CStone and Pfizer to develop and commercialize additional oncology assets for the Greater China market.

"Pfizer’s investment in CStone is a statement of its confidence in the potential of our anti-PD-L1 treatment and recognition of our research and development capabilities," said Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone. "By joining forces with Pfizer and leveraging its commercialization infrastructure, we will ensure that patients across a vastly expanded number of markets in China have quicker access to our highly differentiated PD-L1 treatment. In addition, we have advanced our transformation into a full-fledged biopharmaceutical company by forging a collaboration that will enable us to accelerate development and commercialization of globally innovative therapies for Chinese patients."

"Our company has an extensive and proud history of bringing innovative medicines to patients in China," said Pierre Gaudreault, Acting President of Pfizer Biopharmaceuticals Group China. "This collaboration with CStone builds on that history by helping to develop a potential best-in-class PD-L1 treatment that we can commercialize upon approval. It also fosters our collaboration with a partner that has exceptional clinical development capabilities that can help us meet the clear need for novel oncology treatments in China."

Key Components and Financial Terms of the Collaboration

Pfizer obtains exclusive commercialization rights to sugemalimab in mainland China, while CStone continues to lead clinical development and regulatory strategy for five selected indications.
CStone is entitled to receive up to $280 million in milestone payments for sugemalimab and additional tiered royalties.
CStone retains all development and commercialization rights to sugemalimab outside mainland China.
Pfizer will invest $200 million, consisting of 115,928,803 CStone shares at a price of US$1.725 per share (approximately HK$13.37 per share). As a result of its equity investment, Pfizer will hold a 9.90 percent stake in CStone.
CStone and Pfizer will together select late-stage (post proof-of-concept) oncology assets for co-development in the Greater China market. These assets may come either from Pfizer’s pipeline or through joint in-licensing.
CStone and Pfizer may pursue on a selected basis joint in-licensing arrangements for additional oncology assets for the Greater China market.
The transaction has received the necessary internal approvals of both companies. Closing is not subject to approval by CStone’s shareholders.

Goldman Sachs & Co. LLC is acting as financial advisor to CStone, and Cooley LLP served as legal advisor. Clifford Chance LLP served as Pfizer’s legal advisor.

Investor Presentation Information

CStone will host a live webcast at 11:00am (Hong Kong time) on September 30th, 2020. Please find the access information as below.

All other regions: View Source;tp_key=735ccdf3e4
Mainland China: View Source;tp_key=735ccdf3e4
Password (case sensitive): CStone

About Sugemalimab

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by a company based in the U.S., Ligand Pharmaceuticals Inc. (NASDAQ: LGND), sugemalimab is developed using the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 ("IgG4") human antibody, which may reduce the risk of immunogenicity and toxicities in patients, a potentially unique advantage over similar drugs.

Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and 1b stages of the study, sugemalimab showed antitumor activity in multiple tumor types and was well-tolerated.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase I bridging study in the U.S., the clinical programs in China include one multi-arm Phase Ib study for several tumor types, one Phase II registrational study for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV non-small cell lung cancer, gastric cancer, and esophageal cancer.

On September 29, 2020 PMV Pharmaceuticals, Inc., a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutations, reported the closing of its initial public offering of 13,529,750 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 1,764,750 additional shares of common stock, at a public offering price of $18.00 per share (Press release, PMV Pharma, SEP 29, 2020, View Source [SID1234567731]). The aggregate gross proceeds to PMV Pharma from the offering were approximately $243.5 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by PMV Pharma. PMV Pharma’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "PMVP."

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Goldman Sachs & Co. LLC, BofA Securities, Cowen and Evercore ISI acted as joint book-running managers for the offering.

A registration statement relating to the shares sold in the offering was filed with the Securities and Exchange Commission and became effective on September 24, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained for free from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at [email protected]; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at 1-833-297-2926, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at 1-888-474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 29, 2020 ITM Medical Isotopes GmbH, a subsidiary of the biotechnology and radiopharmaceutical group of companies ITM Isotopen Technologien München AG (ITM), Bruce Power, an electricity company, and IsoGen, a joint venture between the two nuclear energy companies Framatome and Kinectrics, reported that Bruce Power and IsoGen have set the first critical milestone for a reliable and consistent irradiation service which will be provided to ITM exclusively for 15 years (Press release, ITM Isotopen Technologien Munchen, SEP 29, 2020, View Source [SID1234567763]). Thereby a dedicated mock-up of the isotope production system was developed for validation, testing and training which will start in fall 2020.

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The medical radioisotope Lutetium-177 (177Lu) will be obtained by irradiating Ytterbium-176 at the Bruce Power Reactors, as contractually stipulated in an exclusive agreement between Bruce Power, IsoGen and ITM Medical Isotopes GmbH. Bruce Power Reactors are uniquely positioned to fulfil the necessary requirements to reach ITM’s high standards validated in a successful feasibility study September last year. The construction of the isotope production system at Bruce Power by IsoGen is currently planned to start in January 2021 once the mock-up has been fully tested. The mock-up is currently in the final phase of engineering, evaluation, and design and will allow validation and training before deploying the isotope production system to Bruce Power’s units.

The intermediate material to be generated at Bruce Power over 15 years will be processed by ITM via its unique manufacturing methodology to the highly pure form of 177Lu, no-carrier-added (n.c.a.) 177Lu (EndolucinBeta), at ITM´s global network of radiopharmaceutical production facilities. N.c.a. 177Lu is supplied by ITM to clinics worldwide and is used as a therapeutic radiopharmaceutical precursor for Targeted Radionuclide Therapy of cancers such as neuroendocrine tumors, prostate cancer, Non-Hodgkin’s lymphoma, bone metastases and several further indications.

Steffen Schuster, CEO of ITM commented: "Seeing the great progress in the development of the isotope production system by Bruce Power and IsoGen, we are confident that this partnership secures another high-quality source of Lutetium-177 for ITM which further increases scalability of our production ensuring a steady supply of n.c.a. Lutetium-177 on a global scale. Our clinical and industry partner’s demand for the radiopharmaceutical precursor no-carrier-added Lutetium-177 is constantly growing and as a company we are dedicated to providing our highly pure radioisotope for Targeted Radionuclide Therapy to cancer patients worldwide."

On September 28, 2020 Sanofi reported the successful completion of its acquisition of Principia Biopharma Inc. ("Principia") for $100 per share in cash (Press release, Sanofi, SEP 28, 2020, View Source [SID1234567678]).

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"The Principia acquisition further strengthens our core areas of autoimmune and allergic diseases, giving us full control of tolebrutinib (SAR442168), as well as additional BTK inhibitors to further develop," said Paul Hudson, Sanofi Chief Executive Officer. "The Principia integration into Sanofi augments our small molecule research capabilities as we look to maintain leadership in the discovery and development of oral medicines for serious illnesses."

The tender offer for all of the outstanding shares of Principia common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Friday, September 25, 2020. The minimum tender condition and all of the other conditions to the offer have been satisfied and on September 28, 2020, Sanofi and its wholly owned subsidiary Kortex Acquisition Corp. ("Purchaser"), accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, Sanofi completed its acquisition of Principia through the merger of Purchaser with and into Principia, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Principia continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

In connection with the merger, all Principia shares not validly tendered in the tender offer have been converted into the right to receive the same $100 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. Principia common stock will cease to be traded on the NASDAQ Global Select Stock Market.

Evercore acted as financial advisor to Sanofi and Weil, Gotshal & Manges LLP acted as its legal counsel. Centerview Partners LLC and BofA Securities, Inc. acted as financial advisors to Principia and Cooley LLP acted as its legal counsel.

On September 28, 2020 Sosei Group Corporation ("the Company") (TSE: 4565) reported that it has been notified by Pfizer that the first subject in a clinical trial has been dosed with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies (Press release, Sosei Heptares, SEP 28, 2020, View Source [SID1234567704]). Achievement of this milestone triggers a payment of $5 million to Sosei Heptares. This candidate was nominated for advancement by Pfizer in June 2019 generating a $3 million milestone payment at that time.

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Pfizer nominated three distinct clinical candidates from the collaboration with Sosei Heptares during 2019, two of which have now subsequently entered clinical trials. The collaboration has leveraged Sosei Heptares’ unique StaR technology and Structure-based Drug Design (SBDD) capabilities to design oral small molecules that modulate different G protein-coupled receptor (GPCR) targets across multiple disease areas of interest to Pfizer.

This candidate is the eighth GPCR-targeted drug candidate to enter clinical trials originating from Sosei Heptares’ StaR technology and structure-based drug design (SBDD) platform.

Dr. Rob Cooke, Chief Technology Officer of Sosei Heptares, said: "The start of this new clinical trial is another great example of the productivity of our StaR technology and structure-based drug design approach. It also highlights our ability to work collaboratively and successfully with leading pharma companies, applying cutting-edge complementary capabilities to discover and develop completely new drug candidates with potential to treat major diseases. We are extremely pleased with the progress being made in our long-term partnership with Pfizer."

About the Agreement with Pfizer

Sosei Heptares and Pfizer entered a multi-target drug discovery collaboration in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

To address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer is responsible for developing and commercializing any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering multiple significant milestone payments from Pfizer resulting from the nomination of new clinical candidates and entry into clinical trials. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a $33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.