"Med introduktionen på First North tog Xspray Pharma ett viktigt steg mot att förverkliga målet att lansera våra tre första produkter på den amerikanska marknaden för cancerläkemedel 2020-2023 (Filing, Xspray, NOV 22, 2017, View Source [SID1234523281]). Verksamheten utvecklas enligt plan och vi arbetar nu med full kraft för att nå våra mål."

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Per Andersson, VD, Xspray Pharma AB (publ)

Tredje kvartalet, jul-sep 2017

Tal inom parentes avser motsvarande period föregående år.

Resultat före skatt uppgick till –2 836 kSEK (–6 724).
Nettoomsättningen uppgick till 100 kSEK (-).
Resultat per aktie1) uppgick till –0,23 SEK (–1,69).
Kassaflöden från den löpande verksamheten uppgick till 46 kSEK (–5 077).
Xspray Pharmas aktier godkändes för notering på First North och började handlas den 28 september.
Inför börsintroduktionen genomfördes en nyemission som inbringade cirka 132 miljoner kronor före emissionskostnader. Bolaget hade efter transaktionen drygt 2 100 ägare.

De först nio månaderna, jan-sep 2017

Tal inom parentes avser motsvarande period föregående år.

Resultat före skatt uppgick till –8 487 kSEK (–13 873).
Nettoomsättningen uppgick till 311 kSEK (691).
Resultat per aktie1) uppgick till –0,69 SEK (–2,36).
Likvida medel uppgick vid periodens slut till 137 679 kSEK (9 371).
Totalt eget kapital uppgick till 161 151 kSEK (7 300).
Kassaflöden från den löpande verksamheten uppgick till –6 963 kSEK (–11 138).

Händelser efter den 30 september 2017

Den 24 oktober presenterade bolaget positiva kliniska resultat för HyNap-Dasa.
Bolaget erhöll godkännande för tre patent i USA avseende HyNap-Dasa, HyNap-Sora och HyNap-Nilo. Tidigare i oktober erhölls produktpatent för komposition och metod i Japan.

1) Resultat efter skatt delat med antalet aktier vid periodens slut.

Storägare utökar innehav i Xspray Pharma och ingår avtal om lock-up

För ytterligare information, vänligen kontakta:
Per Andersson, vd, Xspray Pharma AB (publ)
Mobil: +46 (0)706 88 23 48
E-mail: [email protected]

Denna information är sådan som Xspray Pharma AB ska offentliggöra enligt EU:s marknadsmissbruksförordning och lagen om värdepappersmarknaden. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 22 november 2017 kl. 08:00 CET

Xspray Pharma i korthet

Xspray Pharma AB (publ) är ett produktutvecklingsföretag med flera produktkandidater i klinisk utveckling. Xspray använder sin innovativa patenterade RightSize-teknologi för att utveckla förbättrade samt generiska versioner av marknadsförda cancerläkemedel, i första hand proteinkinashämmare (PKI), för behandling av cancer. Segmentet är det näst största inom onkologiområdet och läkemedelspriserna är mycket höga. Genom bolagets innovativa teknologi kan Xspray komma in som första konkurrent till dagens originalläkemedel utan hinder från sekundära patent. Xsprays mål är att ha tre produkter färdiga för lansering på den amerikanska marknaden under perioden 2020-2023, med en första produktlansering senast 2021. Bolaget har patent på tillverkningsteknologi, utrustning och de resulterande produkterna. Aktierna i Xspray Pharma AB (publ) handlas på Nasdaq First North Stockholm och Redeye är bolagets Certified Adviser.

On November 22, 2017 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and Specialised Therapeutics Asia, an international biopharmaceutical company with strategic focus and expertise in Australia, New Zealand and South East Asia, reported that they have entered into an exclusive agreement under which Specialised Therapeutics will commercialize NERLYNX (neratinib) throughout South East Asia, beginning with Australia, Singapore, Malaysia, Brunei and New Zealand. Currently, Specialised Therapeutics markets Abraxane and other oncology products in these countries (Press release, Prima Biomed, NOV 22, 2017, View Source [SID1234522226]).

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NERLYNX is not approved currently for commercialization outside of the United States. Specialised Therapeutics will be responsible for seeking the requisite regulatory approvals and, once approved, for commercializing NERLYNX in those countries. Puma will receive upfront and milestone payments of up to $4.5 million throughout the term of this agreement, as well as significant double digit royalties on NERLYNX sales in all regions in which Specialised Therapeutics commercializes NERLYNX.

"Our new agreement with Specialised Therapeutics demonstrates our commitment to bringing NERLYNX to patients around the world while continuing to focus our commercial resources on the U.S. market," stated Alan H. Auerbach, Chief Executive Officer and President of Puma. "We are confident this new partnership will help patients in our new partner’s regions access NERLYNX at the earliest opportunity."

"We are thrilled to be selected as Puma’s first international partner able to provide this therapy to women in our region. We plan to expedite access to this important therapy with a Special Access Program, which we expect to open in Australia in the first quarter of 2018. In tandem, we plan to file for Therapeutic Goods Administration (TGA) registration and to seek regulatory approval to market in other countries, including Singapore, Malaysia, Brunei and New Zealand," said Carlo Montagner, Chief Executive Officer of Specialised Therapeutics. "We expect to have regulatory approval for NERLYNX in Australia by the second quarter of 2019."

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DRUG INTERACTIONS:

Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid dosing.
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:

Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

On November 22, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima", the "Company") reported the grant of patent number 2604275 entitled "Use of Recombinant LAG-3 or the Derivatives thereof for Eliciting Monocyte Immune Response" by the European Patent Office (Press release, Prima Biomed, NOV 22, 2017, View Source [SID1234522226]).

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This European patent was filed as a divisional application and follows the grant of the European parent patent, which was issued in August 2013.

The claims of this new patent are geared toward the use of Prima’s lead candidate IMP321 in combination with a chemotherapeutic agent for the treatment of cancer. According to the claims, IMP321 elicits a monocyte-mediated immune response and is administered before, with, or subsequent to administration of the chemotherapeutic agent. Importantly, these granted claims support the application of IMP321 in Prima’s AIPAC clinical trial in metastatic breast cancer in Europe.
The patent expiry date is 3 October 2028.

On November 22, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported its participation in two upcoming investor conferences (Press release, TESARO, NOV 22, 2017, View Source [SID1234522235]). The two conferences are:

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The Citi 2017 Global Healthcare Conference at the Lotte New York Palace in New York, New York on Thursday, December 7. Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, will participate in an analyst-led moderated Q&A from 1:25 to 2:05 PM ET and in meetings with investors.

The Guggenheim Securities 5th Annual Boston Healthcare Conference at the Intercontinental in Boston, Massachusetts on Wednesday, December 13. Tim Pearson, Executive Vice President and CFO of TESARO, will participate in meetings with investors.
A live webcast of the analyst-led Q&A discussion at the Citi conference will be available by visiting the Investors section of the TESARO website at www.tesarobio.com. An archived replay of this webcast will be available on the Company’s website for 14 days following the conference.

On November 22, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported several promotions on its executive leadership team (Press release, Nektar Therapeutics, NOV 22, 2017, View Source [SID1234522231]):

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Stephen Doberstein, Ph.D., has been promoted to Senior Vice President, Research & Development and Chief Research & Development Officer;
Mary Tagliaferri, M.D., has been promoted to Senior Vice President, Clinical Development and Chief Medical Officer;
Jonathan Zalevsky, Ph.D., has been promoted to Senior Vice President, Research and Chief Scientific Officer.
"I am exceptionally pleased to announce today’s promotions which highlight the talent, skill set and extensive achievements of our executive team," said Howard W. Robin, President and CEO of Nektar Therapeutics. "With the growth in the development of Nektar’s unique and wholly-owned immuno-oncology portfolio and our submission of an NDA filing for NKTR-181, it is critical that we have the right leadership in place to drive the continued success of our pipeline and the company."

Dr. Doberstein has over 25 years of experience in biotechnology research and development. Since joining Nektar in January 2010, he has spearheaded the discovery team at Nektar, which led to the identification and growth of the company’s proprietary pipeline of drug candidates. This included development of NKTR-181 (a first-in-class opioid analgesic with strategic brain entry kinetics) and NKTR-214 (a CD122-biased agonist that is currently in multiple clinical studies across a wide range of tumor types). Dr. Doberstein also serves as a representative of Nektar for the National Institute of Health (NIH) Public/Private Initiative to Address the Opioid Crisis. Prior to joining Nektar, Dr. Doberstein was Vice President of Research at XOMA where he was responsible for directing discovery and development of multiple drug candidates, including antibody discovery and support of clinical development through non-clinical safety, translational medicine and pharmacokinetics/pharmacodynamics. Previously, Dr. Doberstein served as Vice President, Research at Five Prime Therapeutics, a protein and antibody discovery and development company where he built and led the discovery research and process development group. While at Five Prime, he created several successful drug candidate programs that resulted in multiple strategic alliances with pharmaceutical partners, and moved a number of product candidates from concept to clinical stage in diabetes, oncology, rheumatoid arthritis and osteoarthritis. Prior to that, Dr. Doberstein was the Vice President of Research at Xencor, and also held senior leadership positions at Exelixis.

Dr. Tagliaferri has 20 years of experience in pharmaceutical drug development in oncology and women’s health as well as extensive regulatory expertise. Dr. Tagliaferri joined Nektar in January 2015 as Vice President, Clinical Development. During her tenure at Nektar, she has provided strategic development leadership for the company’s immuno-oncology portfolio, including NKTR-214, a CD122 biased agonist, which is in multiple clinical studies across a wide range of tumor types. She serves as strategic development leader for the clinical collaboration between Nektar and Bristol-Myers Squibb. Prior to joining Nektar, she was a clinical and regulatory consultant to InterMune before its acquisition by Roche. She also served as Chief Medical Officer at KangLaiTe USA, a privately-held biotechnology company which develops oncology drug candidates in multiple solid tumor settings. Dr. Tagliaferri was also co-founder and President and Chief Medical Officer of BioNovo where she led the company’s clinical drug development strategy and global regulatory affairs, led data management and biostatistics, and oversaw clinical operations and compliance. Dr. Tagliaferri received the 2012 State of California Woman of the Year award for her advancements of clinical research in women’s health and her mentorship of women in the biotechnology field.

Dr. Zalevsky joined Nektar in July 2015 as Vice President of Biology and Preclinical Development to lead biological and translational research and guide strategy for the Nektar discovery portfolio. During his tenure at the company, Dr. Zalevsky’s expertise in immunology, as well as his experience across biological modalities and therapeutic areas, have helped fuel the growth of the company’s immuno-oncology and immunology pipeline. Dr. Zalevsky led the discovery and preclinical development for NKTR-358 (a T regulatory cell stimulatory agent being developed for auto-immune diseases with partner Eli Lilly & Co.) and NKTR-262 (a small molecule TLR agonist being developed in combination with NKTR-214). Prior to joining Nektar, Dr. Zalevsky had over 15 years of experience within both large pharmaceutical and small biotechnology companies. Previously, Dr. Zalevsky was Global Vice President and Head of the Inflammation Drug Discovery Unit at Takeda Pharmaceuticals. As the leading immunologist for Takeda, he was responsible for an immunology pipeline that spanned from early target discovery to late-stage development and launched products. Prior to working at Takeda, Dr. Zalevsky held a number of research and development positions at Xencor, where he was responsible for the discovery and development of Xencor’s first four clinical-stage assets.