On October 3, 2022 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that the Company has submitted the AMNOG dossier to "The Federal Joint Committee" (G-BA) in Germany (Press release, Oncopeptides, OCT 3, 2022, View Source;germany-first-market-301639005.html [SID1234621651]). This initiates the commercial launch of Pepaxti (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched.

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On August 18, the European Commission granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

"The launch of Pepaxti in Germany is an important milestone for Oncopeptides and very good news for patients with triple class refractory disease," says Jakob Lindberg, CEO of Oncopeptides. "Multiple myeloma is an incurable disease, and despite the recent introduction of several novel therapies, there is a high unmet medical need that Pepaxti may satisfy, in particular in the large population of elderly patients with relapsed refractory multiple myeloma."

Oncopeptides will launch Pepaxti with a focused and lean organization, dedicated to providing patient access for the drug in Germany and Austria. The ex-manufacturer price amounts to 5.450 € per vial, concluding an average price of 10.900 € per cycle/month. The price reflects the clinical benefit for patients in the approved indication. The price is valid for one year and will be subject to negotiations with the National Association of Statutory Health Insurance Funds to set a reimbursed price for German sick funds.

According to data from more than 60 sick funds in Germany in 2020, the prevalence of multiple myeloma is estimated to 59.000 patients and the annual incidence of diagnosed patients is approximately 9.200 cases. The indicated population for Pepaxti in Germany amounts to around 2.500 patients.

On October 3, 2022 Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pantherna Therapeutics GmbH (CEO:Klaus Giese, Ph.D., "Pantherna") reported that the companies have entered into a new technology evaluation agreement for research to generate mRNA-based regenerative medicine programs using direct reprogramming (transdifferentiation)* (Press release, Astellas Pharma, OCT 3, 2022, View Source [SID1234621650]).

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This agreement expands the scope of the technology evaluation agreement for research, which Astellas and Pantherna entered into in 2021, to include new target organ.

Pantherna owns a proprietary platform of state-of-the-art, unique mRNA molecules (PTXmRNAs) for enhancing the efficiency of mRNA actions in the body. Under the new agreement, Pantherna’s mRNA platform and Astellas’ world-class drug discovery capabilities will be combined to promote research on the generation of regenerative medicine programs for new target organ using a direct reprogramming approach. Astellas will be responsible for providing drug discovery ideas, preparing candidate compounds for technology evaluation, and performing research aimed at developing this therapeutic modality, while Pantherna will be responsible for providing technical information and development support.

"We are excited about this expansion of our collaboration with Astellas," said Pantherna’s Chief Executive Officer, Klaus Giese, Ph.D. "We feel honored that Astellas, as a leading pharmaceutical company, has underscored their interest in leveraging the unique aspects of our proprietary therapeutic mRNA technology."

"Through this agreement, which expands the scope of our collaboration with Pantherna, we will create innovative regenerative medicine programs for new target organ, and we expect that we will be able to thereby expand the treatment options for diseases with high unmet medical needs." said Taiji Sawamoto, Ph.D., Executive Vice President, Applied Research & Operations, at Astellas. "The collaboration with Pantherna is an initiative which synergistically integrates Astellas’ expertise with mRNA as a therapeutic modality and its capabilities cultivated in the research field of direct reprogramming, and will promote the development of next-generation treatments using a new modality/technology based on the Focus Area approach strategy."

* Direct reprogramming: Direct conversion of the fate of cells without passing through the pluripotent state. View Source

On October 3, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel (LSAM-DTX), has been published in Drug Delivery and Translational Research (DDTR) (Press release, NanOlogy, OCT 3, 2022, View Source [SID1234621649]).

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The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel (LSAM-PTX), published in DDTR in 2020.

Highlights from the current article:

LSAM-DTX is retained in the tumor as a depot for continuous drug release after intratumoral injection in a range of solid tumor preclinical models.
LSAM‑DTX in combination with an immune checkpoint inhibitor demonstrated synergy in a preclinical metastatic breast cancer model.
Evidence of efficacy is seen in preclinical xenograft models of bladder, prostate, and renal cancer as well as evidence of an abscopal effect in a preclinical syngeneic renal cell adenocarcinoma model.
In the high risk nonmuscle invasive bladder cancer clinical trial arm (n=19) of a dose escalation/expansion trial of intramural and intravesical LSAM-DTX in urothelial carcinoma, 100%/78%/50% of subjects in the high-dose cohort (n=9) achieved a complete response at the 3/6/12 month timepoints respectively. Moreover, evidence suggesting favorable immunomodulation was reported after analysis of suitable tissue samples collected pre/post administration of LSAM-DTX.
In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity.

Taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322), Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology.

On October 3, 2022 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") reported the commercial launch of ALYMSYS (bevacizumab-maly), a biosimilar referencing Avastin (Press release, Amneal Pharmaceuticals, OCT 3, 2022, View Source [SID1234621648]). ALYMSYS is a vascular endothelial growth factor inhibitor used in oncology. This product was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals.

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"The launch of ALYMSYS provides additional access and choice to affordable oncology therapeutics for providers and patients. As a new entrant to the fast growing $28 billion U.S. biosimilars market, we are leveraging our commercial expertise in the Buy and Bill injectable space and have built a dedicated biosimilar commercial team. We look to be an exceptionally customer centric organization and support stable, system wide adoption of ALYMSYS and our biosimilars to come as a long-term player in this space," said Harsher Singh, SVP of Amneal Biosciences.

"Amneal has officially entered the U.S. biosimilar market. Beyond these initial launches, we are working to expand our biosimilars portfolio with additional molecules where we can be early to market and vertically integrate over time. Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible," said Chirag and Chintu Patel, Co-Chief Executive Officers.

According to IQVIA, U.S. annual sales for bevacizumab for the 12 months ended July 2022 were $2.4 billion, $1.7 billion of which represented biosimilar sales.

About ALYMSYS

ALYMSYS (bevacizumab-maly) in the U.S. is a vascular endothelial growth factor inhibitor indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
First-Line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel.
Recurrent glioblastoma in adults.
Metastatic renal cell carcinoma in combination with interferon alfa.
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel.
Limitations of Use: ALYMSYS is not indicated for adjuvant treatment of colon cancer.

IMPORTANT SAFETY INFORMATION includes warnings and precautions on severe and fatal hemorrhage; arterial and venous thromboembolic events; hypertension, hypertensive crisis, and hypertensive encephalopathy; renal injury, proteinuria, and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo-fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; surgery and wound healing complications, and infusion-related reactions.

ADVERSE REACTIONS

Reported adverse drug reactions in patients include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, taste alteration, dry skin, and lacrimation disorder.

On October 3, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of investigational genetic therapies for rare childhood disorders with high unmet need, reported the pricing of an underwritten public offering of 6,800,000 shares of its common stock at a public offering price of $14.75 per share (Press release, Rocket Pharmaceuticals, OCT 3, 2022, View Source [SID1234621646]). The gross proceeds to Rocket from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $100.3 million. All shares in the offering are to be sold by Rocket. In addition, Rocket has granted the underwriters a 30-day option to purchase up to an additional 1,020,000 shares of its common stock. The offering is expected to close on or about October 6, 2022, subject to customary closing conditions.

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Morgan Stanley, J.P. Morgan and SVB Securities are acting as joint book-running managers, and BTIG is acting as lead manager for the offering.

The shares are being offered by Rocket pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov.

When available, copies of the final prospectus supplement relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at (866) 718-1649, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at [email protected]; or SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]. You may also obtain a copy of this document free of charge by visiting the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or jurisdiction.