On July 26, 2022 Prestige Biopharma Limited (hereafter referred to as "Prestige") and Intas Pharmaceuticals Limited (hereafter referred to as "Intas") reported that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma´s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan (Press release, Prestige BioPharma, JUL 26, 2022, View Source [SID1234616947]).

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Prestige´s bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development (SAMSON-II) and the US and EU filing is planned next year. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin.

The partnership arrangement includes the exclusive rights for Intas and its affiliate Accord Healthcare that will commercialize the bevacizumab biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan, leveraging their strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. As one of the key players in the global biosimilar market, Accord has a longstanding commitment to oncology with proven commercial capabilities and it currently supplies around one in three injectable oncology medicines in Europe.

This collaboration represents the successful execution of the company’s strategy to expand its market reach in Europe and Canada leveraging Accord’s strong global footprint and deep commercial expertise. The global sales of bevacizumab including its biosimilars were recorded at USD 6.4 billion1) last year and the market is expected to continue growing. Prestige’s HD204 with excellent cost competitiveness based on the company’s proprietary bevacizumab production technology will be providing affordable access to more patients in need.

Lisa S. Park, CEO of Prestige Biopharma, commented: "We are delighted to establish a partnership with Intas for the key markets, the US and Europe. Accord is the ideal partner to commercialize our bevacizumab biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets."

Binish Chudgar, Vice Chairman & Managing Director of Intas Pharmaceuticals, commented: "We are pleased to announce the collaboration with Prestige Biopharma. This collaboration is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar drugs for cancer patients globally."

On July 26, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported preliminary fourth quarter 2022 Vyleesi product sales (Press release, Palatin Technologies, JUL 26, 2022, View Source [SID1234616946]). Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

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"We are pleased with Vyleesi’s momentum and our preliminary product sales results for the quarter ended June 30, 2022," stated Carl Spana, Ph.D., President and CEO of Palatin. "Our operating results, which includes significant increases across all sales and distribution value metrics, compared to both the prior quarter and the comparable quarter in 2021, continue to demonstrate Vyleesi’s potential within the female sexual healthcare market."

Preliminary fourth quarter ended June 30, 2022 Vyleesi results:

Net product revenue increased 225% over the prior quarter;
increased 600% over the comparable quarter in 2021.
Gross product sales increased 75% over the prior quarter;
increased 90% over the comparable quarter in 2021.
Total prescriptions dispensed increased 45% over the prior quarter;
increased 50% over the comparable quarter in 2021.
Preliminary Financial Information
The Vyleesi related financial and operating data for the fourth quarter of fiscal 2022 is preliminary and may change. This preliminary data has been prepared by, and is the responsibility of, Palatin’s management and no independent accounting firm has audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial data. There can be no assurance that Palatin’s actual results for this quarterly period will not differ from the preliminary financial and operating data and such changes could be material. In addition, Palatin’s estimate of Vyleesi product sales for the fourth quarter of 2022 should not be viewed as a substitute for full financial statements for the fourth quarter and full year of fiscal 2022 prepared in accordance with U.S. generally accepted accounting standards. Additional information that will be material to investors will be provided in the financial statements for the three and twelve months ended June 30, 2022, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided herein.

About Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD.

Palatin is actively seeking Vyleesi collaborations for North America and for territories outside the currently licensed territories of China and Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea.

Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

On July 26, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported an update of its financial guidance for 2022, after preliminary completion of the latest evaluation of MorphoSys’ half year 2022 financial performance (Press release, MorphoSys, JUL 26, 2022, View Source [SID1234616945]).

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MorphoSys updates its financial guidance based on the preliminary unaudited consolidated results for the first six months 2022 and following the recent licensing agreements with Human Immunology Biosciences, Inc. (HIBio) for felzartamab and MOR210. Preliminary Monjuvi (tafasitamab-cxix) U.S. Net Product Sales are US$ 23.3 million (€ 21.7 million) for the second quarter of 2022 and US$ 41.9 million (€ 38.3 million) for the first half year 2022. For the full year of 2022, MorphoSys now expects Monjuvi U.S. Net Product Sales in the range of US$ 90 to US$ 110 million (previously: US$ 110 to US$ 135 million). Further, MorphoSys now expects R&D expenses in the range of € 275 to € 300 million (previously: € 300 to € 325 million) and SG&A expenses in the range of € 150 to € 165 million (previously: € 155 to € 170 million). The previous financial guidance for 2022 was provided by MorphoSys on January 7, 2022 and reiterated on March 16 2022 and May 4, 2022 and can be found at www.morphosys.com. Guidance for Gross Margin for Monjuvi U.S. Net Product Sales remains unchanged.

On July 26, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the fourth quarter of 2022 (Press release, Merck & Co, JUL 26, 2022, View Source [SID1234616944]). Payment will be made on Oct. 7, 2022, to shareholders of record at the close of business on Sept. 15, 2022.

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On July 26, 2022 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), reported a strategic realignment of its pipeline and resources to achieve key clinical milestones (Press release, Humanigen, JUL 26, 2022, View Source [SID1234616941]). The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia ("CMML"), a rare blood cancer, for which the PREACH-M study is already underway. Humanigen will also advance its plan to study lenzilumab in acute graft versus host disease ("aGvHD") that occurs in patients undergoing bone marrow transplant, which will be the focus of the RATinG study that is expected to enroll its first patient in 3Q22. These studies are majority funded by our clinical partners.

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As part of this realignment, Humanigen expects to significantly reduce its go-forward, cash-based operating expenses including elimination of ongoing lenzilumab manufacturing, significant reduction in other R&D costs, and some reduction in general and administrative expenses through headcount reduction as well as other initiatives.

Key elements of the strategic realignment plan include:

·Advancing and expanding the ongoing PREACH-M study of lenzilumab for the treatment of high-risk chronic myelomonocytic leukemia ("CMML") in patients with NRAS, KRAS, and CBL genetic mutations to more rapidly reach the initial clinical assessment of this open-label study once sufficient patients have received three cycles of treatment with lenzilumab in addition to azacitidine. Three patients have been enrolled in the study and followed for multiple cycles, all with encouraging results.

oThe current standard of care for CMML are hypomethylating agents such azacitidine and decitabine, which historically have a complete response rate of 11%-22% according to the International Working Group Criteria.1,2,3

oAustralian clinical partners plan to open additional sites in Australia and may also expand the study to centers in New Zealand.

oHumanigen plans to support expansion of the study to U.S. sites and has received approval from the Principal Investigator to share the protocol and provide monitoring to those additional sites.

The incidence of CMML in the US, UK, and Australia is about 1,700 patients annually.4 As a rare disease, lenzilumab may qualify for certain regulatory and commercial advantages that may accelerate development and approval. Humanigen and the Principal Investigator are assessing regulatory pathways that may enable early results to support a regulatory submission and potential approval by the Therapeutic Goods Administration in Australia, which could be expanded through Project Orbis to the United States and the United Kingdom.

There have been no new therapeutic agents for patients with high-risk CMML in 30 years5 and independent publications have demonstrated the key role of GM-CSF and RAS pathway mutations in this and other cancers, including juvenile myelomonocytic leukemia ("JMML"), myelodysplastic syndromes, myeloproliferative neoplasms, and acute myeloid leukemia.6,7,8

oA clinical protocol is also being developed for JMML with NRAS, KRAS, PTPN11 and/or NF1 genetic mutations

·Continuing to execute the RATinG study for lenzilumab for the early treatment of aGvHD with the goal of reporting a planned interim assessment of the first 20 patients in 2Q23

oThe study is being run and funded primarily by the IMPACT partnership; a group of transplant centers located in the UK.

oLenzilumab will be administered to patients that are identified as having markers for high-risk steroid refractory aGvHD, a population known to have four-fold higher mortality than those identified as low-risk using the same biomarkers.9

·Identifying and supporting further clinical assessment of lenzilumab for prevention of CAR-T therapy related toxicities through an investigator-initiated trial

oPhase 1 ZUMA-19 study completed and target dose defined for further study.

oHumanigen to provide lenzilumab to investigators free of charge to support investigator-initiated trials.

·Seeking potential inclusion of lenzilumab in international, large-scale COVID-19 platform studies through partnerships

·Planning to continue the development of ifabotuzumab, an EphA-3 targeted monoclonal antibody currently in phase 1 development, as part of an antibody drug conjugate, for certain solid tumors.

·Eliminating long-term debt on the balance sheet by fully retiring the Company’s senior secured term loan, reducing interest expense, and enhancing our ability to generate additional liquidity from our intellectual property by freeing it from the loan’s collateral requirements

"We remain committed to advancing the scientific effort to prove the clinical benefits of neutralizing GM-CSF in life-threatening conditions for patients and have had to take difficult though necessary measures to do so," said Cameron Durrant, Chairman and CEO, Humanigen. "Sharpening our in-house pipeline focus and partnering other resource-intensive programs may enable Humanigen and its clinical partners to rapidly derive important data in these indications. Our CMML, aGvHD programs are already primarily funded by partners and we hope to utilize a similar approach with our other programs, reducing our cash-based R&D expenses. We believe this strategic plan offers an opportunity to return value to our stockholders while providing hope to patients with serious and life-threatening conditions for improved outcomes."