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Ipsen reports solid sales growth in first quarter 2020 with limited COVID-19 impact

On April 22, 2020 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales for the first quarter of 2020 (Press release, Ipsen, APR 22, 2020, View Source [SID1234556488]).

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Aymeric Le Chatelier, Chief Executive Officer and Chief Financial Officer of Ipsen stated: "Thanks to the resilient Specialty Care product portfolio, the Group delivered solid sales growth in the first quarter with limited impact from COVID-19. Our priorities in these unprecedented times are to ensure the safety of our employees as well as driving business continuity so patients can maintain access to important medicines. Our 2020 guidance remains suspended until we have more visibility.

"During the first quarter, we received authorization to re-initiate dosing of palovarotene in patients with FOP and are now focused on working with the FDA and other agencies on defining a regulatory path forward with the objective of bringing palovarotene to FOP patients as quickly as possible.

"Thanks to the continued commitment and dedication of our people around the world, we are mobilized to face the COVID-19 pandemic. Together, we will continue to advance and strengthen our pipeline and drive growth and sustainability to fulfill our mission of improving patients’ lives."

First quarter sales

Continuing its growth trajectory, Ipsen achieved solid Group sales growth of 9.6% as reported, or 8.7%1 at constant exchange rates in the first quarter of 2020.

Specialty Care sales growth of 12.5%1, reflecting continued strong double-digit growth of Somatuline (lanreotide) and the continued growth of Cabometyx (cabozantinib) and Decapeptyl (triptorelin).
Consumer Healthcare sales down by 21.9%, mainly related to China with the negative impact of the implementation of hospital central procurement and COVID-19.

COVID-19 update

In the first quarter of 2020, the business remained strong with COVID-19 having a limited impact on sales due to increased stocking in the Oncology portfolio in some European countries toward the end of first quarter. This offsets a lower demand in China in February and March which had a significant impact on the Consumer Healthcare portfolio.

Ipsen continues to operate all of its manufacturing sites and is closely monitoring the situation. There is an adequate level of inventory with no supply chain issues anticipated to continue providing medicines to patients. There is also limited impact to date on clinical trials, with minimal disruption to investigational drug supply for ongoing patients, despite a general slowdown in the recruitment of new patients as well as new site activations in ongoing trials across Europe and the U.S.

Ipsen remains focused on ensuring that patients continue to have access to their treatments and on addressing the impact of this pandemic in their communities. Most Ipsen employees around the world, excluding mainly those at the manufacturing and distribution sites, are working from home today, and the commercial organization continues to support healthcare providers virtually.

In the second quarter of 2020, the situation in China should improve as business begins to resume. However, despite Ipsen’s sustainable and resilient Oncology portfolio comprised mostly of highly-differentiated long-acting treatments for critical conditions, there is expected to be some impact from delayed diagnoses and lower new patient gains. It is also anticipated that there will be more of a negative impact on Dysport sales and revenues in both the therapeutics and aesthetics markets with delayed injections.

2020 Guidance

As announced in March 25th, the 2020 guidance remains suspended due to the lack of visibility on all the consequences of the global COVID-19 pandemic despite a resilient Oncology portfolio. It is not possible at this stage to quantify the impact on the Group’s financial statements. Further updates will be provided as the situation evolves.

Palovarotene update

In the last few months, Ipsen made significant progress on advancing palovarotene, a top priority for the company. On 26 March 2020, clearance was received from the U.S. Food and Drug Administration (FDA) and other regulatory authorities to re-initiate palovarotene dosing in patients 14 years of age and older in the fibrodysplasia ossificans progressiva (FOP) clinical program. It was also decided to terminate the Phase 2 MO-Ped trial in patients with multiple osteochondromas (MO) in order to analyze the accumulated data and to better inform on the efficacy, safety and future of palovarotene in MO. A Complete Response was recently submitted to address the FDA’s questions related to the partial clinical hold on patients under 14 years of age in palovarotene trials.

Positive topline results from pivotal Phase 3 CheckMate -9ER trial

CheckMate -9ER, a pivotal Phase 3 trial evaluating Cabometyx in combination with Opdivo (nivolumab) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).

The safety profiles of Cabometyx and Opdivo observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.

Detailed results of CheckMate -9ER will be submitted for presentation at an upcoming medical conference.

2020 Near-term priorities

Ipsen remains focused on the following near-term priorities:

COVID-19: Ipsen will effectively manage the developing situation of COVID-19 by ensuring the safety of all employees and business continuity for patients as well as preparing for business recovery including protecting profitability and cash flow generation.
CEO search: The board of directors is progressing with its search for a new CEO with no delay expected due to COVID-19.
Palovarotene program: Ipsen intends to engage with the FDA and other regulatory authorities on the appropriate patient population eligible for treatment and a potential regulatory path forward for palovarotene in FOP.

2020 Annual Shareholders’ Meeting and proposed distribution of €1.00 per share confirmed

The Annual Shareholders’ Meeting will be held on 29 May 2020 behind closed doors, without the physical attendance of shareholders. It will be broadcast via a link provided on Ipsen’s website. Ipsen will request its shareholders to cast their votes remotely and submit their questions in advance.

Furthermore, the company confirms the proposed distribution of €1.00 per share for the 2019 financial year to be paid on 5 June 2020. The ex-dividend date is set for 3 June 2020.

Conference call details

Ipsen will hold a conference call on Wednesday, 22 April 2020 at 2:30 p.m. (Paris time, GMT+1). Participants should dial in to the call approximately 15 minutes prior to its start. Participants can register for the call on the link below:

View Source

A recording will be available for seven days on Ipsen’s website.

[1] At constant exchange rates. Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.

Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

On April 22, 2020 Novartis reported that the US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL) (Press release, Novartis, APR 22, 2020, View Source [SID1234556487]). Kymriah, which is designed to be a one-time treatment, is the first-ever FDA-approved CAR-T cell therapy. The potential approval in r/r FL will be the third indication for Kymriah, which also has indications in r/r pediatric and young adult acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL).

"This designation supports the advancement of Kymriah, which could potentially address an unmet need in certain patients with follicular lymphoma, as we strive to reimagine medicine at Novartis. These patients are often faced with the burden of several years of various treatments as their disease continues to progress." said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.

Follicular lymphoma, the second most common form of non-Hodgkins lymphoma (NHL)1,2, is an indolent lymphoma, and represents approximately 22% of NHL cases1. Despite new treatments that improve overall survival, FL is regarded as an incurable malignancy with a relapsing and remitting pattern3. Although patients in third or later line treatment for FL have multiple systemic therapies available, the efficacy of these regimens drops off rapidly in later lines4. Throughout the lifetime of a relapsing FL patient, they may be exposed to a median of five lines of prior treatment, with an upper range of 12 lines5,6. There also is an unmet need in people who are refractory to treatment or quickly relapse, who may exhaust treatment options while they are still healthy enough to receive active treatment4.

The RMAT designation program is part of the 21st Century Cures Act. The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition. The FDA granted RMAT designation for Kymriah in FL based on preliminary clinical evidence from the ELARA clinical trial, an ongoing multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia which was first-of-its-kind in CAR-T research and development.

Kymriah (tisagenlecleucel) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient’s healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.

After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.

Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.
Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.

Invitae to announce first quarter 2020 financial results on May 5, 2020

On April 21, 2020 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its first quarter 2020 financial results on Tuesday, May 5, 2020 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, APR 21, 2020, View Source [SID1234561379]).

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the Conference ID for both is 9557177. Please note after dialing in, you will be prompted to enter the Conference ID and then the pound "#" sign to enter the call. The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].

CYCLACEL ANNOUNCES PRICING OF $20 MILLION PUBLIC OFFERING

On April 21, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported the pricing of a public offering with expected total gross proceeds of approximately $20 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Cyclacel, APR 21, 2020, View Source [SID1234556584]).

Roth Capital Partners is acting as the lead placement agent for the offering. Ladenburg Thalmann and Brookline Capital Markets, a division of Arcadia Securities, LLC are acting as co-placement agents for the offering.

The securities offered by the Company consist of (i) 4,000,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and (ii) common warrants to purchase up to 4,000,000 shares of common stock. Each share of common stock and, as applicable, each pre-funded warrant, is being sold together with a common warrant to purchase one share of common stock at a combined effective price to the public of $5.00 per share and accompanying common warrant, and/or $4.999 per pre-funded warrant and accompanying common warrant. For each pre-funded warrant the Company sells, the number of shares of common stock the Company is offering will be decreased on a one-for-one basis. The common warrants will be immediately exercisable at a price of $5.00 per share of common stock and will expire five years from the date of issuance. The shares of common stock and/or the pre-funded warrants, and the accompanying common warrants, can only be purchased together in the offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on April 23, 2020, subject to customary closing conditions.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (the "SEC") and was declared effective on April 20, 2020. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Myovant Sciences to Host Webcast and Conference Call at 8:30 a.m. Eastern Time Wednesday, April 22 to Discuss Results from Phase 3 SPIRIT 2 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis and from Ovulation Inhibition

On April 21, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women’s health and prostate cancer, reported it will hold a webcast and conference call beginning at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on Wednesday, April 22, 2020, to discuss results from the Phase 3 SPIRIT 2 study of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis (Press release, Myovant Sciences, APR 21, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-webcast-and-conference-call-830-am-2 [SID1234556503]). The company will also discuss results from a separate ovulation inhibition study with relugolix combination therapy.

Webcast/Teleconference Details
To participate in the live conference call, please dial 1-800-532-3746 for domestic callers and +1-470-495-9166 for international callers. A live webcast of the conference call will also be available on the investor relations page of Myovant’s website at investors.myovant.com and will remain archived on Myovant’s website for at least 30 days.