Entry into a Material Definitive Agreement

On September 30, 2019, Dova Pharmaceuticals, Inc., a Delaware corporation ("Dova"), reported that it entered into an Agreement and Plan of Merger (the "Merger Agreement") with Swedish Orphan Biovitrum AB (publ), a Swedish public limited liability company ("Sobi"), and Dragonfly Acquisition Corp., a Delaware corporation and an indirect wholly owned subsidiary of Sobi ("Purchaser") (Filing, 8-K, Dova Pharmaceuticals, OCT 3, 2019, View Source [SID1234540034]). The Merger Agreement provides that, upon the terms and subject to the conditions thereof, as promptly as practicable (but in no event more than ten business days following the date of the Merger Agreement), Purchaser will commence a tender offer (the "Offer") to purchase each issued and outstanding share of common stock of Dova, $0.001 par value per share (the "Shares"), at an offer price of (i) $27.50 per Share, net to the seller thereof in cash, without interest and subject to any withholding taxes (the "Cash Amount"), plus (ii) one non-transferable contingent value right per Share (each, a "CVR", and, the Cash Amount plus one CVR, collectively, or any higher amount per Share paid pursuant to the Offer, the "Offer Price"), which will represent the right to receive $1.50, net to the seller thereof in cash, without interest and subject to any withholding taxes, upon the achievement of a specified milestone (the "Milestone Payment"), pursuant to the terms of the Contingent Value Rights Agreement in the form attached as Annex II to the Merger Agreement (the "CVR Agreement"). Promptly following the completion of the Offer, upon the terms and subject to the conditions of the Merger Agreement, Purchaser will be merged with and into Dova, with Dova surviving as a wholly owned indirect subsidiary of Sobi (the "Merger"). The Merger Agreement contemplates that the Merger will be effected pursuant to Section 251(h) of the Delaware General Corporation Law (the "DGCL"), which permits completion of the Merger without a vote of the holders of Shares upon the acquisition by Purchaser of a majority of the outstanding Shares. At the effective time of the Merger (the "Effective Time"), each Share, other than the Shares accepted for payment in the Offer and shares held by stockholders who validly exercise appraisal rights under Section 262 of the DGCL or by Dova, Sobi or their respective wholly owned subsidiaries, will be cancelled and converted into the right to receive the Offer Price.

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Under the terms of the Merger Agreement, Purchaser’s obligation to accept and pay for Shares that are tendered in the Offer is subject to the satisfaction or waiver of customary conditions, including: (i) the condition that, prior to the expiration of the Offer, there have been validly tendered and not validly withdrawn a number of Shares that, together with Shares then owned by Purchaser and its affiliates, would represent at least one Share more than 50% of the then outstanding Shares; (ii) the expiration or termination of the applicable mandatory waiting period (and any extensions thereof) applicable to the Offer under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; (iii) the accuracy of Dova’s representations and warranties in the Merger Agreement, subject to specified materiality qualifications; (iv) compliance by Dova with its covenants in the Merger Agreement in all material respects; (v) the absence of any change or effect which has had a material adverse effect on the business, assets, financial condition, or results of operations of Dova and its subsidiaries taken as a whole (subject to customary carveouts) that is continuing; and (vi) the absence of legal restraints prohibiting the consummation of the transactions.

The Merger Agreement provides that at the Effective Time: (i) all outstanding options (whether vested or unvested) that have an exercise price of less than $27.50 will be cancelled and the holders thereof will be entitled to receive the Offer Price in respect of each Share covered by such option, less the applicable exercise price; and (ii) all outstanding restricted stock units (whether vested or unvested) will be cancelled and the holders thereof will be entitled to receive the Offer Price in respect of each Share covered by such restricted stock unit. In addition, any options with an exercise price between $27.50 and $29.00 would also be entitled to receive a payment in respect of each Share covered by such option in the event that the Milestone Payment occurs in an amount equal to the excess of $29.00 over the applicable exercise price.

The Merger Agreement contains customary representations, warranties and covenants for both Dova and Sobi, including a covenant regarding the use of Sobi’s and Dova’s reasonable best efforts to cause the conditions to the transactions contemplated by the Merger Agreement to be satisfied. In addition, Dova has agreed to certain non-solicitation obligations related to alternative acquisition proposals.

The Merger Agreement provides certain termination rights for both Dova and Sobi and further provides that a termination fee of $32 million will be payable by Dova to Sobi upon termination of the Merger Agreement under certain circumstances, including if the board of directors of Dova enters into a transaction agreement in respect of a "superior offer" or if Sobi terminates the Merger Agreement as a result of an adverse change recommendation of the board of directors of Dova.

Concurrently with the execution and delivery of the Merger Agreement, Paul B. Manning (and certain related entities) and Sean Stalfort (each such person or entity, a "Tendering Stockholder") entered into Tender and Support Agreements (each, a "Tender Agreement") with Sobi and Purchaser, pursuant to which each Tendering Stockholder agreed, among other things, to tender his, her or its Shares into the Offer and, if necessary and subject to the terms of the Tender Agreement, vote his, her or its Shares (i) in favor of any matter necessary to the consummation of the transactions contemplated by the Merger Agreement and considered and voted upon by the Dova stockholders, (ii) against any alternative acquisition proposal, (iii) against the adoption of any definitive agreement in respect of an alternative acquisition proposal and (iv) against any other action that would in any manner (A) change the voting rights of any class of capital stock of Dova or (B) otherwise reasonably be expected to prevent, materially interfere with or materially impede the Offer or the Merger.

The Tendering Stockholders are generally prohibited from transferring their Shares (subject to certain exceptions), and over a majority of Dova’s outstanding Shares are covered by the Tender Agreements. However, in the event the board of directors of Dova makes an adverse change recommendation in compliance with the terms of the Merger Agreement, the number of Shares that would continue to be covered by the Tender Agreements would be decreased to 30% of the outstanding Shares.

The foregoing description of the Merger Agreement does not purport to be complete and is qualified in its entirety by the full text of the Merger Agreement, a copy of which is filed as Exhibit 2.1 hereto and is incorporated by reference herein. The Merger Agreement has been attached to provide investors with information regarding its terms. It is not intended to provide any other factual information about Sobi, Purchaser or Dova. In particular, the representations, warranties and covenants of each party set forth in the Merger Agreement have been made only for the purposes of, and were and are solely for the benefit of the parties to, the Merger Agreement, may be subject to limitations agreed upon by the contracting parties, including being qualified by a confidential disclosure letter made for the purposes of allocating contractual risk between the parties to the Merger Agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. The confidential disclosure letter contains information that modifies, qualifies and creates exceptions to the representations and warranties and certain covenants set forth in the Merger Agreement. Accordingly, the representations and warranties may not describe the actual state of affairs at the date they were made or at any other time, and investors should not rely on them as statements of fact.

CVR Agreement

Pursuant to the Merger Agreement, at or prior to the effective time of the Merger, Sobi and a rights agent (the "Rights Agent") will enter into the CVR Agreement governing the terms of the CVRs issued as part of the Offer Price. The Rights Agent will maintain an up-to-date register of the holders of CVRs (the "Holders"). Holders shall not be permitted to transfer CVRs (subject to certain limited exceptions).

Each CVR will entitle its Holder to receive $1.50 upon approval of avatrombopag for the treatment of Chemotherapy-Induced Thrombocytopenia by the United States Food and Drug Administration. Sobi has agreed to use "Diligent Efforts" (as defined in the CVR Agreement) to achieve the foregoing milestone.

The foregoing summary of the principal terms of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full form of the CVR Agreement, a copy of which is included as an exhibit to the Merger Agreement filed as Exhibit 2.1 hereto and incorporated by reference herein.

Corporate Slide Presentation as of October 3, 2019

On October 3, 2019 Oncternal Therapeutics presented the corporate presentation (Presentation, Oncternal Therapeutics, OCT 3, 2019, View Source [SID1234540033]).

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Clarity Receives US FDA response on its Theranostic Investigational New Drug (IND) Application that the study may proceed

On October 3, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported that it has received a response on its Investigational New Drug (IND) application that the study may proceed from the U.S. Food and Drug Administration (FDA) for a Phase 1-2a theranostic (i.e. diagnostic and therapy) trial with 64Cu-SARTATE and 67Cu-SARTATE in paediatric patients (Press release, Clarity Pharmaceuticals, OCT 3, 2019, View Source [SID1234540032]).

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This trial will be using Clarity’s lead product, SARTATE, administered to paediatric patients with somatostatin receptor-2 positive, relapsed or refractory, high-risk neuroblastomas. It is a multi-centre, dose escalation, open-label, non-randomised, Phase 1-2a theranostic clinical trial planned for up to 34 patients using 64Cu-SARTATE for PET imaging and 67Cu-SARTATE for therapy.

The FDA response suggests not only the importance of the study in the treatment of neuroblastoma, but also validates the manufacturing of 64Cu-SARTATE and 67Cu-SARTATE to levels suitable for diagnostic and therapeutic use, as well as the suitability of the centralised manufacturing concept of this theranostic pairing.

Neuroblastoma is a disease that occurs most often in infants and young children, usually in children younger than 5 years old. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 13% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.

This study is supported by a human imaging study in 10 adults with neuroendocrine tumours and preliminary results of a first-in-human study of adult patients with meningioma, who were administered a diagnostic dose of 64Cu-SARTATE followed by up to four doses of the therapeutic product,67Cu-SARTATE.

Dr Alan Taylor, Clarity’s Executive Chairman, commented on the IND approval "The acceptance of Clarity’s first IND application in a relatively short time indicates the quality and importance of work conducted by our preclinical, clinical and manufacturing teams in the field of theranostics and reflects the support for the development of novel treatments for children with cancer. We are very pleased to have achieved this significant milestone. Our Team is looking forward to progressing this trial at some of the leading cancer centres in the U.S. and we are hoping to commence recruitment shortly which will get us one step closer to our goal of better treating children and adults with cancer."

Media Contact
Dr Alan Taylor

Executive Chairman

Ph: +61 (0)413 871 165

E: [email protected]

Lantheus to Acquire Progenics to Form a Leading Precision Diagnostics Imaging and Therapeutics Company

On October 2, 2019 Lantheus Holdings, Inc. (NASDAQ: LNTH) ("Lantheus"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, and Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported a definitive agreement for Lantheus to acquire Progenics in an all-stock transaction. The transaction has been unanimously approved by the Boards of Directors of both companies.

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Under the terms of the agreement, Lantheus Holdings will acquire all of the issued and outstanding common shares of Progenics stock at a fixed exchange ratio. Progenics shareholders will receive 0.2502 shares of Lantheus Holdings stock for each share of Progenics stock, representing approximately a 35% aggregate ownership stake in the combined company. The exchange ratio implies a 21.5% premium to Progenics’ 30-day volume weighted average closing stock price ("VWAP").1

Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer. Progenics takes a leading role in developing diagnostics that help guide physicians and therapeutics that treat patients. The company’s oncology-focused portfolio currently includes three FDA approved products as well as a rich product pipeline. AZEDRA, approved in July 2018, is the first and only FDA approved product used to treat adult and pediatric patients 12 years and older for the ultra-orphan indications of pheochromocytoma and paraganglioma. Progenics’ other approved products are oral and subcutaneous formulations of RELISTOR, which are licensed to Bausch Health Companies Inc.

The combination of Lantheus and Progenics forms an innovative company with a diversified diagnostic and therapeutics portfolio. The transaction leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities. Anchored by Lantheus’ leading microbubble franchise, the resulting company’s robust portfolio includes additional radiopharmaceutical products for precision diagnostics and therapeutics in the field of oncology as well as a related artificial intelligence platform with a 510(k) approved application in oncology. The two companies had pro forma combined revenue of $370.1 million for the 12 months ended June 30, 2019.

"A long-term pioneer in medical diagnostics, Lantheus remains an industry leader in radiopharmaceuticals as well as the world-wide leader of ultrasound contrast agents. With this combination, we broaden our reach in emerging uses of radioisotopes for precision diagnostics and the exciting and expanding field of radiopharmaceuticals in oncology treatment," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Lantheus will be a leader in radiopharmaceutical innovation, providing medical professionals with essential tools and therapies to diagnose and treat neuroendocrine tumors and prostate cancer patients. Our complementary strengths, radiopharmaceutical manufacturing and supply chain expertise, and focus on commercial execution will deliver sustainable and diversified revenue streams and increase our gross margin potential. We have assessed the strategic fit with Progenics for a number of years and I am pleased that we are finally able to make this combination come to fruition; I believe that the combined company will be well positioned for long-term value creation for all of our stockholders."

"Today marks the beginning of an exciting new chapter for Progenics. This combination unlocks additional value for stakeholders and stockholders alike through Lantheus’ enhanced resources and R&D capabilities, proven commercial expertise and complementary portfolio of products. The transaction also creates value for Progenics stockholders through a significant premium and the opportunity to participate in the future growth of Lantheus," said Mark Baker, Chief Executive Officer of Progenics. "Lantheus shares our confidence in the potential of our promising pipeline, and we believe that Lantheus will provide additional commercialization expertise and resources to further advance AZEDRA’s launch and deliver substantial revenue growth. This compelling opportunity would not have been possible without the hard work and dedication of our talented employees. We have gotten to know Lantheus’ Board and management team extremely well as we have discussed this combination over the past nine months and we look forward to working together to continue developing innovative products to target diseases and improve treatment for patients around the world."

Upon completion of the acquisition, which is intended to be tax-free to Progenics’ stockholders for U.S. federal income tax purposes, the combined company will continue to be headquartered in North Billerica, Massachusetts and will trade on the NASDAQ under the ticker symbol: LNTH.

The combined company will be led by Lantheus Chief Executive Officer Mary Anne Heino, who brings 30 years of diverse life sciences industry experience with deep pharmaceutical and operational expertise, including commercializations across complex market channels that will help maximize the success of Progenics’ development pipeline and commercial assets. Ms. Heino will be supported by Chief Financial Officer Robert J. Marshall Jr., CFA, who brings over three decades of finance experience, including in healthcare M&A, capital markets, investor relations and corporate financial planning and analysis, and Chief Operations Officer John Bolla, who has over 22 years of diverse supply chain, global operations and manufacturing experience from pilot to full-scale manufacturing of complex pharmaceutical products. Following the closing, Bradley Campbell, currently a member of Progenics’ Board of Directors, will be added as a member of the Board of Directors of Lantheus Holdings.

Compelling Strategic and Financial Rationale

Robust portfolio of precision diagnostic and therapeutic products: With complementary strengths and products, the resulting company will serve patients and healthcare professionals across the continuum of critical diagnosis and care. Progenics enhances Lantheus’ R&D platform, combining to form an innovative development portfolio of precision diagnostics and oncology therapeutics.

Sustainable and diversified revenue growth: This transaction bolsters and diversifies Lantheus’ revenue growth, which is anchored by DEFINITY’s continued strong performance and the expansion of its microbubble franchise. The combined company will focus on advancing the successful commercialization of AZEDRA to drive revenue growth and on maximizing the value of its development pipeline, which we believe has significant market potential. Supported by Lantheus’ proven manufacturing, supply chain and clinical development expertise in the field of radiopharmaceuticals, the combination is expected to drive enhanced revenue growth over the long term.

Attractive returns and enhanced cash flow generation potential: Through enhanced revenue growth and significant realizable cost savings opportunities through the elimination of redundant costs and process and scale efficiencies, Lantheus is expected to improve its gross margin profile into the future. The company expects to generate approximately $15 to $20 million in run-rate cost savings by 2022. These savings are related primarily to public company costs and G&A expenses. With improved top line growth, operational execution and synergy opportunities, the transaction is expected to enhance the company’s cash flow generation and be accretive to adjusted and reported EPS by 2022 and 2023, respectively.

Experienced executive management team: The combined company will be led by a management team with deep experience in the development, manufacturing and commercialization of precision diagnostics and radiopharmaceuticals, and will continue to deploy a team of highly specialized field personnel. The Lantheus Board of Directors is committed to overseeing and incentivizing management to ensure alignment with stockholders’ interests.

Additional Transaction Details

The transaction is expected to close in the first quarter of 2020, subject to approval by Lantheus and Progenics stockholders, regulatory approvals, and customary closing conditions.

Advisors

SVB Leerink LLC is acting as financial advisor and White & Case LLP is acting as legal counsel to Lantheus. Jefferies LLC is acting as financial advisor to Progenics and O’Melveny & Myers LLP is acting as its legal counsel.

Conference Call and Webcast Details

Lantheus and Progenics will hold a conference call on Wednesday, October 2, at 8:00 Eastern Time. To access the live conference via telephone, please dial 1 (866) 498-8390 (U.S. callers) or 1 (678) 509-7599 (international callers) and provide passcode 5441618. A live audio webcast of the call also will be available at https://lantheusprogenics.transactionannouncement.com/, and replay of the audio webcast will be available approximately two hours after completion of the call and will be archived for 30 days.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

(Press release, Progenics Pharmaceuticals, OCT 2, 2019, View Source [SID1234670312])

BerGenBio to Present Clinical Data From Phase II Trial With Selective AXL Inhibitor at 34th Annual SITC Meeting

On October 2, 2019 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting, which is being held from 6-10 November 2019 in Maryland (Press release, BerGenBio, OCT 2, 2019, View Source [SID1234540031]).

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The presentation will provide updates on its phase II study of bemcentinib (BGB324) in combination with pembrolizumab in patients with advanced NSCLC.

Abstract titles have been announced online at View Source (abstracts # O26). Details of the presentation are below.

Title: A phase II study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis.

Date: Friday 8th November 2019

Time: 5:10 pm – 5:25 pm (during High Impact Clinical Trials session)

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.