On July 29, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that it has entered into a securities purchase agreement with Frazier Healthcare Partners for the private placement of 851,306 shares at $17.62 per share (Press release, Crinetics Pharmaceuticals, JUL 29, 2021, View Source [SID1234585392]). The private placement will yield gross proceeds of $15.0 million and is expected to close on August 2, 2021, subject to the satisfaction of customary closing conditions.

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"We are extremely pleased that an investor like Frazier Healthcare Partners supports our vision to become the leading endocrinology company pioneering novel therapeutics for patients to address unmet medical needs," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.

Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Crinetics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement.

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

On July 29, 2021 Nuvo Pharmaceuticals Inc. (TSX: NRI) (OTCQX: NRIFF) d/b/a Miravo Healthcare ("Miravo" or the "Company"), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported that its wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC trading as Miravo Healthcare ("Miravo Ireland"), reported that it has entered into an exclusive license and supply agreement (the "License Agreement") with SK Chemicals Co., Ltd. ("SK Chemicals") for the exclusive right to commercialize Suvexx in the Republic of South Korea (the "Territory") (Press release, Nuvo Pharmaceuticals, JUL 29, 2021, View Source [SID1234585409]).

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SK Chemicals is headquartered in Seongnam, South Korea and is part of the SK Group, a major South Korean conglomerate that generated over US$105 billion in revenue in 2020. SK Chemicals generated US$1.0 billion in sales in 2020 and has Korean partnerships with many multinational pharmaceutical companies including Eli Lilly, AstraZeneca and Janssen.

The commercial launch of Suvexx in the Territory is anticipated to commence in 2023, subject to receipt of regulatory approval from the local regulatory authorities. Upon regulatory approval, Suvexx is anticipated to be entitled to 6 years of marketing exclusivity in the Territory. The South Korean prescription acute migraine treatment market was valued at over US$20 million in 2020 based on IQVIA domestic data.

"This agreement with SK Chemicals provides Suvexx with access to the dynamic and growing acute migraine market in South Korea," said Jesse Ledger, Miravo’s President & CEO. "SK Chemicals is a strong partner for Suvexx in South Korea with their complementary CNS product portfolio, and we are pleased to add them to our growing roster of Suvexx partners."

License Agreement Details

The License Agreement grants SK Chemicals the exclusive rights to commercialize Suvexx in the Territory. SK Chemicals will be responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and will also manage all Territory specific commercial activities. Miravo Ireland will receive up to EUR 1.1 million in upfront consideration, regulatory and sales-based milestone payments, as well as royalties on net sales of Suvexx in the Territory and revenue pursuant to the supply of product. Suvexx is currently manufactured by the Company’s contract manufacturing partner in the United States.

About Suvexx

Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. ("POZEN") in collaboration with Glaxo Group Limited, d/b/a GSK ("GSK"). The product is formulated with POZEN’s patented technology (now owned by Miravo) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK’s RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration ("FDA") approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Miravo owns the product and intellectual property rights to Suvexx in Canada and Miravo Ireland owns the intellectual property rights to Suvexx outside of Canada.

On July 29, 2021 Addex Therapeutics Ltd (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that it has extended its research collaboration agreement with Indivior PLC (LON: INDV) (Press release, Addex Therapeutics, JUL 29, 2021, View Source [SID1234585453]). As part of the extension, Indivior has committed $4 million of new funding to advance development of selected novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates discovered by Addex. The new funding will be used to prepare drug candidates for both Indivior’s substance use disorder program and Addex’s proprietary Charcot-Marie-Tooth type 1A neuropathy program, which are both expected to start IND enabling studies in 2022.

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"This additional committed research funding, which will be used to prepare lead drug candidates for IND enabling studies, demonstrates the quality of Addex’s drug discovery platform and the significant achievements made in our Indivor collaboration," said Tim Dyer, CEO of Addex. "In addition, we have seen great progress in the rest of our portfolio, including dipraglurant entering a pivotal study in PD-LID and our partner, Janssen, advancing ADX71149 into a Phase 2a POC for epilepsy."

"Excellent progress has been made in our research collaboration with Addex," said Christian Heidbreder, Chief Scientific Officer of Indivior. "With this new funding, Indivior has reiterated its commitment to advance this novel allosteric approach towards clinical evaluation. The Addex collaboration forms part of our continued strategy of finding novel therapeutic approaches to treat the serious and growing need of people suffering with substance use disorders."

About GABAB Activation with PAM

Activation of gamma-aminobutyric acid subtype B (GABAB) receptor, a Family C class of GPCR, is clinically & commercially validated. The generic GABAB receptor agonist, baclofen, is marketed for spasticity and some spinal cord injuries, and used for overactive bladder (OAB), but it is not commonly used due to a variety of side effects and rapid clearance. Potent, selective oral positive allosteric modulators (PAM) that potentiate GABA responses at the GABAB receptor, rather than an orthosteric agonist at the GABAB receptor like baclofen, only act when the natural ligand (GABA) activates the receptor, therefore respecting the physiological cycle of activation. It has been proposed that PAMs produce less adverse effects and could lead to less tolerance than direct agonists (May and Christopoulos 2003; Langmead and Christopoulos 2006; Perdona et al. 2011; Urwyler 2011; Gjoni et al., 2008; Ahnaou et al).

Seagen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On July 29, 2021 Prokarium, a biopharmaceutical company pioneering the oncology field of microbial immunotherapy, reported the appointment of Uz Stammberger, MD, as Chief Medical Officer (Press release, Prokarium, JUL 29, 2021, View Source [SID1234585322]). In the role, Dr. Stammberger will lead the advancement of Prokarium’s oncology pipeline into the clinic.

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"Uz brings extensive clinical experience to Prokarium’s team having spent more than two decades in oncology drug development and research," said Kristen Albright, PharmD, Chief Executive Officer of Prokarium. "We are thrilled to welcome Uz onboard as we expand our clinical portfolio into oncology, and I look forward to working together on the development of our next generation immuno-oncology pipeline."

"Prokarium’s unique technology based on live, attenuated bacteria is a promising and powerful strategy for reprogramming the tumor microenvironment and eliciting long-lasting anti-tumor effects," said Dr. Stammberger. "I am excited to exploit the full therapeutic capabilities of our proprietary bacteria in both the monotherapy and combination settings, with our lead program targeting bladder cancer, an indication in which there remains a significant unmet medical need for patients."

Dr. Stammberger joins Prokarium from the Novartis Institutes for BioMedical Research, where he oversaw the MAPK assets in Translational Clinical Oncology and generated several PoCs/PoMs in different genetically defined solid tumors. Prior to his role at Novartis, Dr. Stammberger was a Clinical Lead at Merck KGaA, responsible for Tepotinib, a small molecule inhibitor of c-Met which is approved in the US and Japan for MetEx14 skip mutant NSCLC. Earlier in his career, he held various positions at Roche and Boehringer Ingelheim. Dr. Stammberger received his Doctor of Medicine as well as the Venia docendi (Adj. Professor of General Thoracic Surgery) from the University of Bern and is a board-certified GP and surgeon.