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Knight Therapeutics to Acquire Regional Rights to Exelon®

On April 23, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight") a pan-America (ex-USA) specialty pharmaceutical company, reported that it has entered into a definitive agreement under which Knight will acquire the exclusive rights to manufacture, market and sell Exelon (rivastigmine Patch, Capsules and Solution) in Canada and Latin America (the "Territory"), as well as an exclusive license to use the intellectual property and the Exelon trademark, from Novartis within the Territory (Press release, Knight Therapeutics, APR 23, 2021, View Source;id=202438&p=2193050&I=1206939-c7Z3G6f3m8 [SID1234578415]).

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Exelon (rivastigmine) is a prescription product that was first approved in 1997 and is currently registered and sold in approximately 90 countries. Exelon is indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease.

At closing, Knight will pay USD $168 million in cash and an additional milestone payment of up to USD $12 million upon the achievement of certain conditions. Exelon had annual revenues for 2020 of approximately 47 Million US dollars for Canada and Latin America.

"We are excited to add Exelon to our portfolio of specialty CNS products and continue to support this well established and important therapy option in an area of such high unmet need as Alzheimer’s", said Samira Sakhia, President and Chief Operating Officer of Knight.

"The acquisition of Exelon leverages Knight’s pan-American (ex-US) platform and further validates our Rest-of-world strategy", said Amal Khouri, Chief Business Officer of Knight. "Exelon will be the first product that we will be selling across our entire territory".

The closing of this transaction is subject to anti-trust clearance in Brazil. In conjunction with closing, Knight will enter into a transition service agreement until transfer of marketing authorization, on a country by country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country by country basis.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss the Exelon acquisition today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Friday, April 23, 2021
Time: 8:30 a.m. ET
Telephone: Toll Free 888-506-0062 or International 973-528-0011
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at https://www.gud-knight.com

Protara Therapeutics Provides Regulatory Update for TARA-002 for the Treatment of Lymphatic Malformations

On April 23, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported a path forward related to TARA-002 for the treatment of Lymphatic Malformations (LMs), which are rare malformations of the lymphatic vasculature for which there is no U.S. Food and Drug Administration (FDA)-approved treatment (Press release, Protara Therapeutics, APR 23, 2021, View Source [SID1234578413]). Based on feedback from the FDA, the Company intends to complete confirmatory, large-scale, GMP manufacturing comparability in the second half of 2021 and subsequently initiate a clinical study in pediatric LM patients pending alignment with FDA on study design.

"With the benefit of the recent FDA feedback, we will work with the agency to align on a clinical study in pediatric LM patients, which, we believe, combined with the existing dataset for OK-432 (the originator compound for TARA-002), which demonstrated treatment effect and support for strong safety profile in over 500 LM patients, should provide a robust data package for this rare disease," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We have already begun preparation to initiate a clinical study in LMs and we look forward to continued collaboration with FDA to achieve our goal of delivering the first approved medication for LMs to these patients and their physicians."

TARA-002 is derived from the same cell bank as OK-432, a broad immunopotentiator approved in Japan and Taiwan for the treatment of LMs, where it is currently the standard of care. In 2020, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and the originator compound OK-432, which has been studied in more than 500 patients in one of the largest Phase 2 trials ever conducted in LMs. TARA-002 has been granted Rare Pediatric Disease designation by the FDA for the treatment of LMs.

About Lymphatic Malformations

Lymphatic malformations (LMs) are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of 3 years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

Molecular Partners Files Registration Statement for Proposed Initial Public Offering in the United States

On April 23, 2021 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), representing common shares, in the United States (the "Offering") (Press release, Molecular Partners, APR 23, 2021, View Source(SIX%3A%20MOLN,SEC%E2%80%9D)%20relating%20to%20a%20proposed [SID1234578412]). All securities to be sold in the Offering will be offered by the Company. The number of common shares to be represented by each ADS, the number of ADSs to be offered and the price range for the ADSs in the proposed Offering have not yet been determined. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "MOLN." The Company’s common shares are listed on the SIX Swiss Exchange ("SIX") pursuant to its International Reporting Standard under the ticker symbol "MOLN."

JP Morgan, SVB Leerink and Cowen & Co. are acting as joint lead bookrunners for the Offering. RBC Capital Markets is also acting as bookrunner and Kempen & Co is acting as lead manager for the Offering.

The securities referred to in this announcement are to be offered only by means of a prospectus. When available, copies of the preliminary prospectus may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105.

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The common shares underlying the ADSs are expected to be listed on the SIX. In connection with this listing, the registration statement on Form F-1, once declared effective, constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 ("FinSA") and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 ("FinSO").

Cytokinetics to Announce First Quarter Results on May 6, 2021

On April 22, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report first quarter results on May 6, 2021 at 4:00 PM Eastern Time (Press release, Cytokinetics, APR 22, 2021, View Source,4%3A00%20PM%20Eastern%20Time. [SID1234578409]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 6097958.

An archived replay of the webcast will be available via Cytokinetics’ website until May 20, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 6097958 from May 6, 2021 at 7:30 PM Eastern Time until May 20, 2021.

Anavo Therapeutics Launches with EUR 20 Million Seed Financing to Create Industry-Leading Pipeline of Allosteric Phosphatase Modulators

On April 23, 2021 Anavo Therapeutics, a global leader in unlocking the full therapeutic potential of human phosphatase biology, reported with a EUR 20 million (approx. $24 million) seed financing (Press release, Anavo Therapeutics, APR 23, 2021, View Source [SID1234578407]). Anavo’s mission is to pioneer systematic drug discovery and development approaches aimed at phosphatases, a rich and largely untapped therapeutic target class. The funds will be used to advance a proprietary drug discovery portfolio in oncology and establish a versatile and robust platform to address the target space broadly across multiple indications. Anavo’s leadership team, Dr. Birgit Zech and Dr. Gerhard Müller, are building on several years of joint experience in the biopharmaceutical industry and have demonstrated the ability to navigate rapidly emerging sectors in biopharma most recently as co-founders of Gotham Therapeutics. The founding team is further complemented by Claus Schalper, a renowned finance expert and serial biotech entrepreneur.

Phosphatases and kinases regulate the activity of numerous crucial signaling pathways by removing or adding a phosphate group from proteins or other biomolecules. Imbalances in this process can lead to a multitude of diseases. While kinases have been exploited by drug developers worldwide, phosphatases stayed largely untouched after setbacks earlier in this century.

Anavo’s approach focuses on combining profound understanding of phosphatase biology with deep drug discovery expertise and state-of-the-art technologies to design first-in-class and best-in-class small molecule modulators of phosphatase activity. The company has attracted world-leading phosphatase biology expertise to its advisory board in Mathieu Bollen, Professor of Molecular Cell Biology at University of Leuven, and Nicholas Tonks, Professor of Cancer Research at Cold Spring Harbor Laboratory. Taken together, both have authored and co-authored more than 500 scientific publications on phosphatases and related physiological processes.

"Anavo was founded to unlock the full potential of phosphatase-targeting allosteric modulators and has attracted one of the largest European biotech seed rounds to date. Recent progress especially around SHP2 has demonstrated that the time is ripe to address phosphatase drug discovery more systematically and on a much larger scale," said Dr. Birgit Zech, Chief Executive Officer of Anavo Therapeutics. "With Mathieu Bollen and Nicholas Tonks as our initial scientific advisory board members, we have attracted two world-leading scientists in phosphatase biology which complements our deep drug discovery know-how."

"Academic research on the human phosphatome has moved way ahead of the industry and we are now sitting on a real treasure trove of potential therapeutic avenues to explore, targets to validate, and programs worth translating into preclinical and clinical evaluation," said Dr. Gerhard Müller, Chief Scientific Officer of Anavo Therapeutics. "Among all target classes currently defined as ‘undruggable’, we expect phosphatases to have the deepest and most profound impact on clinical outcomes once addressed in a systematic and coherent fashion."

Therese Liechtenstein, Principal at M Ventures, added: "Anavo’s novel approach and its experienced management team provide us with the best tools and key ingredients to address challenges in phosphatase drug discovery, and unlock this rich target class. We are excited to be part of Anavo and their mission."

Simone Botti, Junior Partner at INKEF Capital, added: "The progress that has been made with SHP2 in our industry has revived the phosphatase sector but is only scratching the surface of this largely untapped attractive molecular target class. We are very pleased to support Anavo, a company poised to deliver first-in-class therapeutics in oncology and establish itself as a world leader in phosphatase drug discovery."

Therese Liechtenstein and Simone Botti will be joined by Sakae Asanuma, President and CEO of Taiho Ventures, and Debora Dumont, Managing Partner at Bioqube Ventures, on Anavo’s Board of Directors.