On August 9, 2019 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Court of Appeals for the Federal Circuit ruled in favor of Lilly, confirming that the Alimta (pemetrexed for injection) vitamin regimen patent would be infringed by competitors that had stated their intent to market alternative salt forms of pemetrexed prior to the patent’s expiration in May 2022 (Press release, Eli Lilly, AUG 9, 2019, View Source [SID1234538538]).

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The ruling came in the appeals of U.S. District Court decisions in the cases of Eli Lilly and Company v. Dr. Reddy’s Laboratories and Eli Lilly and Company v. Hospira, Inc. Previous rulings in Lilly’s favor had precluded the generic companies from launching the alternative salt forms until the patent expires.

If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force.

"We’re pleased with this decision," said Michael J. Harrington, Lilly’s senior vice president and general counsel. "Lilly’s extensive research to discover this patent deserves intellectual property protection, which has been confirmed in every challenge in the U.S. to date."

On June 22, 2018, Lilly announced that the U.S. District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta vitamin regimen patent would be infringed by the use of Dr. Reddy’s alternative salt form of pemetrexed prior to the patent’s expiration. The district court found the generic product would infringe under the doctrine of equivalents.

In a separate decision on June 15, 2018, the District Court also ruled in favor of Lilly in the case of Eli Lilly and Company v. Hospira, Inc. denying Hospira’s motion for summary judgement and granting Lilly’s cross-motion for summary judgment.

Both Dr. Reddy’s and Hospira had appealed the district court’s decisions, leading to today’s ruling.

In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly’s favor regarding infringement of the vitamin regimen patent. The U.S. Court of Appeals for the Federal Circuit confirmed these rulings in a unanimous decision in January 2017, finding the patent is valid and would be infringed by the generic challengers’ proposed products.

Separately, Lilly announced in April 2019 that the U.S. Court of Appeals for the Federal Circuit ruled in the company’s favor regarding patentability of the vitamin regimen for Alimta, upholding an October 2017 decision by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office.

On August 9, 2019 AstraZeneca reported positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter trial of TAGRISSO in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (Press release, AstraZeneca, AUG 9, 2019, View Source [SID1234538554]).

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TAGRISSO showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of TAGRISSO was consistent with its established profile.

José Baselga, Executive Vice President, Oncology R&D said: "Today’s positive results show that TAGRISSO provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming TAGRISSO as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer."

AstraZeneca plans to present the OS results from the FLAURA trial at a forthcoming medical meeting.

TAGRISSO is currently approved in more than 74 countries, including the US, Japan and the EU, for 1st-line EGFR-mutated metastatic NSCLC.

TAGRISSO IMPORTANT SAFETY INFORMATION

TAGRISSO may cause serious side effects, including:

lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded
eye problems. TAGRISSO may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
Before taking TAGRISSO, tell your doctor about all of your medical conditions, including if you:

have lung or breathing problems
have heart problems, including a condition called long QTc syndrome
have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
have a history of eye problems
are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
Females who are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 6 weeks after the final dose of TAGRISSO
Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the final dose of TAGRISSO
are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your final dose of TAGRISSO. Talk to your doctor about the best way to feed your baby during this time
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO are:

diarrhea
rash
dry skin
changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails
mouth sores
tiredness
decreased appetite
Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is TAGRISSO?

TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used:

as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s)
or

for a certain type of EGFR gene that has been treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working
Your doctor will perform a test to make sure that TAGRISSO is right for you.

It is not known if TAGRISSO is safe and effective in children.

Please see full Prescribing Information including Patient Information.

NOTES TO EDITORS

About lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC. Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC. These patients are particularly sensitive to treatment with EGFR TKIs which block the cell-signaling pathways that drive the growth of tumor cells. Approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis. The presence of brain metastases often reduces median survival to less than eight months.

About TAGRISSO

TAGRISSO (osimertinib) is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases. TAGRISSO 40mg and 80mg once-daily oral tablets have now received approval in more than 70 countries, including the US, Japan and the EU, for 1st-line EGFR-mutated advanced NSCLC, and in more than 80 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. TAGRISSO is also being developed in the adjuvant setting (ADAURA trial), in the locally-advanced unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines (SAVANNAH, ORCHARD).

About FLAURA

The FLAURA trial assessed the efficacy and safety of TAGRISSO 80mg orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was double-blinded and randomized, with 556 patients across 29 countries.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action. We aim to address the unmet needs of patients with EGFR-mutated tumors as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines gefitinib and TAGRISSO, and ongoing Phase III trials FLAURA, FLAURA2, ADAURA and LAURA as well as the Phase III exploratory combination trials SAVANNAH and ORCHARD.

Our extensive late-stage Immuno-Oncology program focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer. Durvalumab, an anti-PDL1 antibody, is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in combination with tremelimumab and/or chemotherapy (AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III trials).

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On August 9, 2019 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported the pricing of its previously announced underwritten public offering of 2,376,238 shares of its common stock at a public offering price of $25.25 per share (Press release, Quanterix, AUG 9, 2019, View Source [SID1234538555]). All of the shares in the offering will be sold by Quanterix. Gross proceeds from the sale of the shares, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $60.0 million. Quanterix has also granted the underwriters a 30-day option to purchase up to an additional 356,435 shares of common stock on the same terms and conditions.

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The offering is expected to close on or about August 13, 2019, subject to customary closing conditions.

J.P. Morgan Securities LLC and SVB Leerink LLC are acting as joint book-running managers for the offering. Canaccord Genuity LLC is acting as co-manager for the offering. Perella Weinberg Partners is acting as independent capital markets advisor to Quanterix for the offering.

The public offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, can be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected].

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

On August 9, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported second quarter 2019 financial results and business updates, which will be discussed on a conference call scheduled for Monday, August 12 at 10:00 a.m. ET (Press release, Abeona Therapeutics, AUG 9, 2019, View Source [SID1234538540]). Interested parties are invited to participate in the call by dialing 844-369-8770 (toll-free domestic) or 862-298-0840 (international) or via webcast at View Source

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"The second quarter was highlighted by progress made in both of our MPS III programs," said João Siffert, M.D., Chief Executive Officer. "Data from our Transpher A study showed that children with MPS IIIA who were treated early with ABO-102 preserved neurocognitive development within the normative range 12-18 months post treatment. Our MPS IIIB program has also progressed, with enrollment of additional patients in cohort 2 of the Transpher B study. Our team remains highly focused on our lead programs, including the start of our VIITAL Phase 3 clinical trial in recessive dystrophic epidermolysis bullosa, continued enrollment in the MPS III programs, and preparations to start the clinical trial in CLN1 disease."

Second Quarter Financial Results:

Cash, cash equivalents and marketable securities as of June 30, 2019, were $62.5 million compared to $68.3 million as of March 31, 2019. The decrease in cash was driven primarily by the net cash used in operating activities of $15.2 million.

Research and development expenses for the second quarter ended June 30, 2019 were $16.3 million compared to $7.9 million in the same period of 2018. The increase in R&D expense was primarily attributable to increased in-house manufacturing activities and related headcount costs.

General and administrative expenses for the second quarter ended June 30, 2019 were $5.6 million compared to $4.6 million in the same period of 2018. The increase in G&A expenses was primarily due to increased headcount and related facility costs.

Net loss was $0.49 per share for the second quarter of 2019 compared to $0.26 per share in the same period of 2018.

Second Quarter and Recent Highlights:

-July 25, 2019: Announced positive interim data from the Phase 1/2 AAV9 gene therapy clinical trial in MPS IIIA showing preservation of neurocognitive function for the three youngest patients treated with ABO-102, as well as robust and sustained improvements in biomarkers of the disease. No product-related serious adverse events were reported to date.
-June 26, 2019: Appointed Dr. Victor Paulus as Senior Vice President of Regulatory Affairs and Jodie Gillon as Vice President of Patient Advocacy and Clinical Affairs
-June 18, 2019: Received FDA Fast Track Designation for ABO-202 AAV9 gene therapy in CLN1 disease
-May 21, 2019: Announced FDA clearance of Investigational New Drug application for ABO-202 AAV9 gene therapy in CLN1 disease
-May 14, 2019: Announced treatment of first patient in second cohort of Phase 1/2 clinical trial for ABO-101 AAV9 gene therapy in MPS IIIB
-May 1, 2019: Reported preclinical data demonstrating broad therapeutic potential of AIM gene therapy in retinal diseases at Association for Research in Vision and Ophthalmology Annual Meeting
-April 30, 2019: Reported preclinical data demonstrating therapeutic potential of ABO-401 for treatment of cystic fibrosis at American Society of Gene and Cell Therapy annual meeting
-April 4, 2019: Received FDA Fast Track Designation for ABO-101 AAV9 gene therapy for MPS IIIB

Steven H. Rouhandeh, Abeona’s Executive Chairman, said, "Abeona has continued the development of its breakthrough gene and cell therapies for rare genetic diseases through 2019 with important regulatory and clinical achievements secured. We look forward to progressing our MPS programs, and to starting of our Phase 3 VIITAL trial in EB before year end."

On August 9, 2019 GeneCentric Therapeutics, Inc. reported that it has entered the second phase of an academic-industry collaboration with Jose Zevallos MD, MPH, Chief of the Division of Head and Neck Oncologic Surgery in the Department of Otolaryngology at Washington University School of Medicine in St. Louis (Press release, GeneCentric Therapeutics, AUG 9, 2019, View Source [SID1234538556]).

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This collaboration is funded by a National Cancer Institute (NCI) R01 grant, awarded in August 2017 to Dr. Zevallos. The grant supports the investigation of novel approaches to improve outcomes for patients with head and neck squamous cell carcinoma (HNSCC). Titled "Development of a Four-Class, Molecular Subtyping Diagnostic for HPV-Negative Head and Neck Cancer," the grant is focused on the development of a clinic-ready tumor subtyping diagnostic test, in collaboration with GeneCentric Therapeutics, that will guide treatment decisions for patients with HPV-negative HNSCC.

The HPV-negative subtyper being applied under this NCI grant is a modified version of GeneCentric’s previously-developed Head and Neck Cancer Subtype Profiler (HNSP). Following successful completion of phase 1 development of a reduced gene-set signature, GeneCentric is poised to commence phase 2 validation studies with Dr. Zevallos and his team. The last stage of the NCI grant, phase 3, entails final confirmation of the HNSCC diagnostic test and commercialization.

"This research has the potential to impact treatment for a broad range of patients with head and neck cancer. Our aim is to better identify cancers that are resistant to radiation therapy. We also hope the test will more accurately identify patients with occult lymph node metastasis and help surgeons make more informed decisions on when surgery to remove neck tumors should be offered to patients," said Dr. Zevallos of the NCI sponsored partnership with GeneCentric.

About GeneCentric Therapeutics Head and Neck Cancer Subtyping Platform (HNSP)

Head and neck cancer, a group of cancers that starts within the mouth, nose, throat, larynx, sinuses, or salivary glands, is the seventh most common of all cancers. Because the majority begin in squamous cells which line the moist surfaces inside the head and neck areas, such cancers are also referred to as Head and Neck Squamous Cell Carcinomas (HNSCC).

These cancers comprise a heterogeneous disease with multiple tumor types, and correspondingly varying prognoses and treatment responses. Advanced HNSCC is associated with a 40-50 percent recurrence rate following primary treatment. Human papilloma virus (HPV) infection is an important risk factor, but infection is present in only a subset of cases and knowledge of HPV status alone is not sufficient to guide treatment. Better classification tools are needed to inform therapeutic choices and improve survival. To address this critical need, GeneCentric has applied its Cancer Subtyping Platform (CSP) to develop a comprehensive profile of head and neck tumor subtypes that can guide drug development, clinical trials and patient treatment. The GeneCentric Head and Neck cancer Subtype Profiler (HNSP) consists of five distinct subtypes, including one specific to HPV-related HNSCC, as determined through our research.