Halozyme Therapeutics INC
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Global Insider Investing - Halozyme Therapeutics Musterdepotaufnahme
10:45 22.07.08
Endingen (aktiencheck.de AG) - Die Experten von "Global Insider Investing" nehmen eine Erstposition der Halozyme Therapeutics-Aktie (Profil) in ihr Musterdepot auf.
Ende Juni habe der Direktor Randal Kirk eigene Aktien im Gesamtvolumen von 55 Mio. USD zu Kursen zwischen 5,55 und 6,02 USD gekauft und dadurch seinen Anteil auf 20% ausgebaut. Inzwischen notiere das Papier bei 7,82 USD. Hier schlummere nach Meinung der Experten aber immer noch einiges an Potenzial. So würden beispielsweise die Analysten von Oppenheimer ein Kursziel von 14 USD sehen.
Halozyme Therapeutics habe bereits mit Cumulase und Hylenex zwei Präparate am Markt, mit denen Umsätze generiert würden. Zudem forsche man derzeit an einem vielversprechenden Mittel gegen Blasenkrebs. Das Präparat trage den Namen Chemophase und habe in aktuellen Phase I/IIa-Testreihen gute Fortschritte gemacht. Im kommenden Jahr wolle man schon mit Phase III der klinischen Tests beginnen.
Die Experten von "Global Insider Investing" nehmen eine Erstposition der Halozyme Therapeutics-Aktie in ihr Musterdepot auf. (Ausgabe 14 vom 21.07.2008) (22.07.2008/ac/a/a)
Quelle: Aktiencheck
im Dezember erfolgte wieder ein Insiderkauf, waren 10.000 Stck vom Direktor persönlich!
gruss macos
First Patient Dosed With Second Roche Biologic Formulated With Halozyme's Recombinant Enzyme Technology Halozyme to Receive Milestone Payment
SAN DIEGO, Jan. 15, 2009 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that Roche has dosed the first patient in a Phase 1 pharmacokinetic clinical trial with a subcutaneous formulation using Enhanze(tm) Technology of a biologic directed to a second Roche exclusive target. This has triggered a milestone payment under the agreement.
"This is the second clinical trial initiated by Roche within a short timeframe and illustrates the rapid and efficient approach Roche is taking to develop different biologicals simultaneously with Enhanze Technology," said Jonathan Lim, M.D., Halozyme's President and CEO.
Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze Technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche paid Halozyme an initial payment for the application of its recombinant human enzyme, rHuPH20, to three pre-defined Roche biologic targets. In December 2008, Roche selected a fourth biologic target and has the option to exclusively develop and commercialize rHuPH20 with an additional nine targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche may pay Halozyme additional milestones as well as royalties on potential future product sales. Under the collaboration, Roche has access to Halozyme's expertise in developing and applying rHuPH20 to Roche targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche target compounds resulting from the collaboration.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze(tm) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter BioScience to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID. Halozyme's research pipeline candidates target significant areas of unmet medical need. For more information visit www.halozyme.com.
The Halozyme Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5750
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning Roche's progress under the collaboration and the potential achievement of various milestones) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.
CONTACT: Halozyme
Robert H. Uhl, Senior Director, Investor Relations
(858) 704-8264
ruhl@halozyme.com
http://www.halozyme.com/
http://media.corporate-ir.net/media_files/irol/17/...heHalozymePR.pdf
http://www.mffais.com/halo.html
Significant Single Agent Anti-Tumor Activity Observed With PEGPH20 in Tumor Models That Accumulate Hyaluronan
Extended Half-Life of PEGPH20 Allows Continued Depletion of Hyaluronan From Tumors Following Systemic Administration
SAN DIEGO, Jan. 26, 2009 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced the presentation of positive pre-clinical animal efficacy data for PEGPH20 (pegylated-rHuPH20 enzyme) monotherapy at the American Association for Cancer Research (AACR) Advances in Prostate Cancer Research meeting in San Diego. The study demonstrated that repeat intravenous treatment with PEGPH20 as a single agent in the PC3 mouse model resulted in approximately 70% (p=0.001) tumor growth inhibition compared to controls.
"This study demonstrates that a sustained depletion of hyaluronan from the tumor microenvironment with PEGPH20 is associated with a suppression of tumor cell expansion," stated Gregory Frost, Ph.D., Halozyme's Chief Scientific Officer. "By treating the tumor as an organ rather than just individual cancer cells, novel complementary approaches to treating this disease may be possible."
Halozyme continues to prepare for the commencement of a Phase 1 single agent clinical trial during the first half of 2009 with intravenously administered PEGPH20 in treatment refractory cancer patients. Additional investigations are also underway to explore combinations of PEGPH20 with other targeted and cytotoxic agents for potential clinical investigation.
Additional Study Results and Details
Various prostate cancer cell lines were screened in vitro for the production of pericellular coats comprised of hyaluronan (HA), the substrate for the PEGPH20 enzyme. Several aggressive prostate cancer cell lines that produce HA-rich coats surrounding the tumor cells collapsed in the presence of PEGPH20. Moreover, PEGPH20 significantly suppressed the growth of coat producing human prostate cancer cells within a three-dimensional matrix in a dose dependent fashion, suggesting such cells require HA to rapidly expand into the surrounding microenvironment.
Treatment of human PC3 prostate tumors in athymic mice with intravenous PEGPH20 resulted in a rapid, dose-dependent depletion of HA from the tumor microenvironment. Accumulation of HA in tumors such as PC3, correlates with increased tumor growth, metastases and elevated interstitial fluid pressure. Continued enzymatic depletion of HA from PC3 tumors with intravenous PEGPH20 was associated with a 70% tumor growth inhibition and an approximate doubling in time to progression. In contrast, no suppression of tumor volume growth or increase in time to progression was observed with PEGPH20 treatment of an HA negative prostate tumor, Du145.
Pegylation refers to the covalent attachment of polyethylene glycol to a molecule, usually a drug or therapeutic protein. The pegylation of rHuPH20 increases its plasma half-life to greater than 24 hours compared to less than one minute for the unpegylated enzyme, therefore resulting in a longer duration of action.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme's Enhanze(tm) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter BioScience to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID. Halozyme's research pipeline candidates target significant areas of unmet medical need. For more information visit www.halozyme.com.
The Halozyme Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5750
gruss macos
Stopp einer Studie
Fall auf $7
Ich investiere nicht in Biotechs weil hier werden Aktionäre sehr oft hinters Licht gefuehrt
The CONSISTENT 1 trial was planned to evaluate Hylenex (hyaluronidase) as infusion site pre-treatment in insulin pump therapy in T1DM patients (n=456) over two years. However, as the FDA will likely request additional clinical data for an update of Hylenex' label, Halozyme Therapeutics has decided to stop the trial after 12 months to focus resources on other projects. Following clarification of the regulatory requirements, the company plans to seek partnering for development and commercialisation. (Halozyme Q3 press release and earnings call, 10 November 2014)
Comment: CONSISTENT 1 met the primary endpoint of non-inferior change in HbA1c vs standard pump therapy at 6 months. Pre-treatment with Hylenex resulted in lower rates of hypoglycaemia. Halozyme has also completed phase 2 development of co-formulations of rapid-acting insulin analogues and hyaluronidase; however, the company has not been able to secure a partnership for phase 3 and commercialisation of these formulations.
http://www.clinicaltrials.gov/ct2/show/NCT01848990
http://www.ariva.de/news/...cer-Patients-Treated-With-PEGPH20-5772168
Scheinbar hat man nun durch gezielte Gegenbehandlung die unerwünschten Nebeneffekte in beiden Versuchsarmen unter Kontrolle gebracht, es bleibt aber zu prüfen, ob der erzielte mögliche Vorteil in der Behandlung das Risiko der möglichen Nebenwirkungen aufwiegen kann. Der nicht signifikante Effekt bei der Überlebensrate und die gegebene Begründung der unterschiedlichen Schwere der Versuchsarme sind noch zu schwach, um hier uneingeschränkt positiv zu reagieren.
Meine Einschätzung - KEINE Handelsempfehlung.
"Halozyme Therapeutics Inc. (NASDAQ:HALO) had its target price upped by equities research analysts at Piper Jaffray Cos. from $15.00 to $18.00 in a note issued to investors on Friday."
Übersicht hier:
https://www.fiercebiotech.com/biotech/...ndpoint-from-pegph20-phase-3
Halozyme schliesst globale Kooperations- und Lizenzvereinbarung mit ArgenX
"Under the terms of the agreement, argenx will pay an upfront payment of $30 million to Halozyme, $10 million per target for future target nominations and potential future payments of up to $160 million per selected target subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products."
https://www.halozyme.com/investors/news-releases/...logy/default.aspx
Halozyme floppt in Phase 3 Studie PEGPH20 (Bauchspeicheldrüsenkrebs)
- rund 55 % der Belegschaft werden entlassen
"With PEGPH20 development now halted, Halozyme says it will close its oncology operations and lay off approximately 160 people—roughly 55 percent of its workforce. More than 80 percent of those job cuts will happen by January 2020. The company says the corporate shakeup will save between $130 million and $140 million next year. Going forward, Halozyme says it will focus on supporting and developing Enhanze, which is used in three commercialized products and 11 drugs that are in clinical testing."
https://xconomy.com/san-diego/2019/11/04/...er-drug-fails-in-phase-3/
Ausblick 2020
- Umsatz 230-245 Mio. $
- EPS 0,60-0,75$
- Aktienrückkaufprogramm
https://www.halozyme.com/investors/news-releases/...ance/default.aspx
Zahlen für Q4/19 und FY19
- FY19 Umsatz 196 Mio. $ (VJ 152)
- Q4/19 Umsatz 54 Mio. $ (VJQ 60)
- Q4/19 Umsatz 54 Mio. $ (VJQ 60)
- FY19 Verlust 72 Mio. $ (VJ 80)
- Q4/19 Verlust 34 Mio. $ (VJQ 2)
- Q4/19 Verlust 34 Mio. $ (VJQ 2)
- Cash 421 Mio. $
- eigene Aktien für ~200 Mio. $ zurückgekauft
- 2020 sollen für ~150 Mio. $ Aktien zurückgekauft werden
- insgesamtes Volumen des Rückkaufprogrammes ~550 Mio. $
https://www.halozyme.com/investors/news-releases/...ults/default.aspx
Lizenzvereinbarung mit ArgenX wird erweitert
https://seekingalpha.com/news/...eement-argenx-for-enhanze-technology