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chemistfrog
i am sorry to post this here but i am limited on the QSGI board.
can you please point out on the QSGI board that most of us longs have not left.
we,like my self are either limited,banned or put in jail for posting positive and counteractive posts to you know who...
please do this for me and others .
it is not fair what is going on there and it is hurting the stock!
thank you
carm
It was a lot tighter, and then some selling today and yesterday took out some of the bids. It'll come back, with a vengeance!! :)
Great article Chemist! Looking to buy in once spread stabilizes :)
CSDT DD
http://seekingalpha.com/instablog/399559-chemistfrog/115378-cascade-technologies-reinvented-and-making-all-the-right-moves
Cascade Technologies – Reinvented and Making all the Right Moves
Cascade Technologies Corporation (OTCBB: CSDT) reinvented itself in March 2010 with its acquisition of Spectral Molecular Imaging, Inc. (SMI), a medical diagnostic imaging company. SMI at the time was developing its initial product, SkinSpect™, aimed at early detection of melanoma by the company's proprietary form of hyperspectral imaging. With this acquisition Cascade Tech has plunged into the medical diagnostic field head-first and has been making key moves to advance the technology and its new lead product. These moves include an accelerated time-frame for the SkinSpect device completion, addition of key personnel and additional funding to move the project closer to FDA trials and marketing.
Since its acquisition, SMI has completed the SkinSpect device which was introduced to colleagues on September 29th and to the public via a press release which was issued on October 7th. At the unveiling Dr. Erik Lindsley, President of SMI, stated that SkinSpect "incorporates advances in hyperspectral imaging, autofluorescence measurement and polarization-gated detection achieved by SMI researchers and consultants through experiences cumulatively reaching more than 100 years. The software controlling image acquisition and handling is completely new, driven by an intuitive touch screen interface and allowing effortless data and patient monitoring, image archiving and analysis, and internet-based data transfer and tele-consults; its design is compliant with and conducive to electronic medical record generation and tracking."
Key to the company’s future and product line is its staff of all-star personnel, not the least of which is Dr. Daniel Farkas, chairman and CEO of SMI. In a September 30th press release, Dr. Farkas was described as “very active in international meetings through the years, having presented about 200 invited and plenary talks, and having organized and chaired 25 international conferences, mostly in biomedical optics. Within the past year, he lectured at the European Biophysics Congress in Genova, Italy; at the Biomedical Optics Society conference in San Francisco; at the Beckman Laser Institute and Medical Clinic at UC Irvine; at the Electrochemical Society Meeting in Vancouver (two talks); at the Association for Research in Vision and Ophthalmology conference in Ft. Lauderdale; at the International Brain Mapping and Intraoperative Surgical Planning Society congress (New Horizons track) in Bethesda; at the World Congress of Minimally Invasive Spine Surgery in Las Vegas; at the Surgical Navigation division of Medtronic Corporation and in the University of Southern California Physical Sciences in Oncology Center Seminar Series. These talks, and the invitations to present them, reflect the diversity and interdisciplinary nature of the applications enabled by the ground-breaking optical bioimaging that constitutes the core of SMI's efforts, and the widespread interest, both scientific and clinical, that they elicit.” Too many times in industry I’ve seen key personnel and the “brains” and developers of technology get pushed aside in the political mix-ups in management. In this case, the key behind getting the product through development and into trials is the gentleman who is actually the CEO of the company, eliminating the bureaucratic “middle men”.
A key addition with regard to the technological advancement of the SkinSpect is its new Chief Technologist, Mr. Robert Chave. Mr. Chave is a former Jet Propulsion Laboratory engineer where he designed and developed instruments and sub-systems with opto-mechanical elements for the Mars Rovers, the James Webb and Hubble Space telescopes, and a U2 aircraft-based spectrometer for monitoring ozone degradation above the earth's poles. While employed at JPL, he was principal investigator on a NASA Advanced Technology Development Grant in Low Temperature Science and Engineering. This research led to the invention of a magnetostrictive super-fluid helium valve, linear and rotary low temperature actuators and related tools with significance for condensed matter physics, astronomy and cryosurgery. Robert was Visiting Research Faculty in the Department of Materials Science at Caltech. This work lead to 12 NASA New Technology awards to him personally and over 20 awards to authors on the project in total. In 2000 he founded RCAppP Inc., a contract design firm that designs, builds and calibrates instruments for clients and end users who have included the Office of Naval Research, the U.S. Departments of Energy, Defense, and Homeland Security, NASA, Los Alamos National Laboratories, Caltech, and the Smithsonian Observatory, as well as private corporations, such as the Idealabs family of companies. This information as well as additional biography on Robert Chave can be found on a press release from October 26th.
Other personnel, though certainly not all, include another former Jet Propulsion Laboratory employee and now current Chief Scientist Dr. Greg Bearman; Dr. Erik Lindsley, President of SMI; Dr. Sam Raz, the new VP of International Business Development and a host of other all-star level people strategically placed in the corporation with pertinent backgrounds, degrees and levels of expertise. In this corporation we see the “Doctor” title in many positions in everything from product development, software implementation and future marketing/current partnership searching (the latter in Dr. Sam Raz, please see PR on him for full potential impact of his expertise).
Key to the development of Cascade Technologies and SMI is the financing of its activities. A November 9th announcement of a $190K grant from the IRS and Department of Health and Human Services certainly bodes well for the company’s finances as well as speaks volumes about the departments’ views of the potential of SkinSpect. “The QTDP grant program provides support for innovative projects that are determined by the USDHHS to have reasonable potential to result in a new therapy, reduce health care costs, or significantly advance the goal of curing cancer.”
In future articles we will discuss MELA Sciences (NASDAQ: MELA), and its MelaFind handheld imaging device and its impact on Cascade Technologies and SMI’s SkinSpect device. The primary focus will be on the FDA Panel’s narrow vote of approval for its device and how SMI views the product. We will also be discussing Cascade Technologies’ recent letter of intent to acquire the assets of AcuNetx, a company that develops and markets non-invasive optical imaging devices for the eyes. A simple look at the headlines for Cascade Technologies in Google Finance and http://www.otcmarkets.com/stock/CSDT/news gives one a sense of how fervently and methodically Cascade Technologies’ SMI division is working under new ownership. Have a long look at Cascade Technologies, and add it to your medical device company watch list to see how its future unfolds. Skin cancer is very prevalent, and its early diagnosis is key to increasing survival, decreasing scarring associated with surgery and keeping healthcare costs down. SMI’s SkinSpect device could potentially become another tool in the arsenal against dermal cancers. Please see the following facts from http://www.skincancer.org/Skin-Cancer-Facts/:
• Skin cancer is the most common form of cancer in the United States. More than 3.5 million cases in two million people are diagnosed annually.
• Each year there are more new cases of skin cancer than the combined incidence of cancers of the breast, prostate, lung and colon.
• One in five Americans will develop skin cancer in the course of a lifetime.
• Basal cell carcinoma (BCC) is the most common form of skin cancer; an estimated 2.8 million BCCs are diagnosed annually in the US. BCCs are rarely fatal, but can be highly disfiguring if allowed to grow.
• Squamous cell carcinoma (SCC) is the second most common form of skin cancer. An estimated 700,000 cases are diagnosed each year in the US, resulting in approximately 2,500 deaths.
• Basal cell carcinoma and squamous cell carcinoma are the two major forms of non-melanoma skin cancer. Between 40 and 50 percent of Americans who live to age 65 will have either skin cancer at least once.
• In 2004, the total direct cost associated with the treatment for non-melanoma skin cancers was more than $1 billion.
CTSO approaches 100 in their cytosorbents enrollment. Additionally, please look at this November 2 PR. Another grant to fund their operations!
Nov 02, 2010 09:25 ET
CytoSorbents Corporation Awarded $488,958 Grant From the Federal Qualifying Therapeutic Discovery Project Program
MONMOUTH JUNCTION, NJ--(Marketwire - November 2, 2010) - CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced the award of a cash grant of up to $488,958 from the Federal Qualifying Therapeutic Discovery Project (QTDP) Program for two products in its pipeline, including the development of CytoSorb™ for the treatment of sepsis and other critical care illnesses.
The QTDP was established by the Patient Protection and Affordable Care Act of 2010 with a limited $1 billion fund to be issued as either a tax credit or a federal tax-free grant to qualifying drug, biotechnology, medical device and diagnostics companies with fewer than 250 employees for research and development costs in qualified therapeutic discovery projects for the tax years of 2009 and 2010. Applications were reviewed in a competitive application process by both the U.S. Department of Health and Human Services and the Internal Revenue Service based on a number of criteria including the potential of new therapies to treat major unmet medical needs and the potential to reduce long-term healthcare costs.
Dr. Phillip Chan, Chief Executive Officer, stated, "We greatly appreciate the recognition of the potential of our platform technology to treat commonly seen, yet devastating critical care illnesses such as sepsis, burn injury, trauma, and severe lung injury, for which few effective therapies exist. Most of us have been touched in some way by these conditions and know first hand how little can be done. With the aid of these grants, we hope to advance our potentially game-changing technology to help critically ill people around the world."
About CytoSorbents and CytoSorb™
CytoSorbents Corporation, and its operating subsidiary CytoSorbents, Inc., is a critical care focused therapeutic device company in clinical trials to treat severe sepsis, often called "overwhelming infection," with a novel blood purification device called CytoSorb™. Severe sepsis afflicts more than 1 million people in the United States and an estimated 18 million people worldwide each year, killing one in every three patients despite the best treatment. In the United States, more die from severe sepsis than from either heart attacks, strokes or any single form of cancer. Severe sepsis is typically triggered by bacterial infections like pneumonia, or viral infections like influenza. However, it is the body's abnormal immune response to the trigger that leads to severe inflammation and the unregulated, massive production of cytokines, often called "cytokine storm," that then causes multi-organ failure and often death. CytoSorb™ is a cartridge containing highly porous polymer beads that are designed to filter cytokines and treat potentially fatal cytokine storm. As blood is pumped repeatedly through the CytoSorb™ cartridge using standard dialysis equipment, the beads bind and remove cytokines and other toxins from blood. The treated blood is then returned to the patient. The Company is currently conducting its European Sepsis Trial -- a multi-center, randomized, controlled clinical trial using CytoSorb™ to treat up to 100 patients with severe sepsis in the setting of respiratory failure. Pending a successful trial, the Company will seek CE Mark approval and commercialization of CytoSorb™ in the European Union. Importantly, cytokine reduction via CytoSorb™ has broad applicability to a number of other critical care diseases where cytokine storm plays a detrimental role, including burn and smoke inhalation injury, trauma, acute respiratory distress syndrome, advanced influenza, acute pancreatitis and other. CytoSorb™ is one of a number of different resins designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy during treatment of cancer with high dose regional chemotherapy, drug detoxification and others. Additional information is available for download on the Company's website: www.cytosorbents.com.
UYMG volume well above 10-day average. Financials that are posted on pinksheets.com as of October 14th show acquisition "target" financials. This looks to be a done deal!
Hi Ray,
Did you get the message that it was moved to Tuesday or Wednesday? Hopefully, we'll see a PR on it Monday or Tuesday?
Take care! This should be the week when it gets going!
Chemistfrog
Chemistfrog, what time is the conference call on UYMG tonight, also do you have the phone number, thx?
Hi, FYI Financials posted on pinksheets as of today w/income now
Chemistfrog, I think its a great time to add from .007 to .009 top area, if you see from yesterday's L2 all 3 MM's had ask @.007 then NITE came in and ate that up and the ask went directly to .01 for awhile, now todays L2 .0085,then .0089 then .01, I dont think we will see sub penny on this for much longer, especially if tonights call goes well, what time is it at anyways?
Hi Ray! Nice to hear from you! I'll do some DD on those later this evening. Right now, I'm getting ready to focus on the UYMG conference call tonight. I'm debating about whether to add to my position or to hold tight. What do you think?
Oh, here's my newest article. It's on Ariad Pharmaceuticals. They will be reporting phase III results and likely filing NDA by the end of the year on their sarcoma cancer drug. Have a look?
Take care and get back with you on your stocks this evening! :)
http://seekingalpha.com/instablog/399559-chemistfrog/101189-results-of-merck-ariad-pharmaceuticals-synergistic-collaboration-coming-soon
Hey Chemistfrog, how have you been? Whats ur thoughts on TBJK, SNEY & ICOA??
THX
Great comment! Looking for a good week!
Unity Management Group’s (Pinksheets: UYMG) surprise move today to retire approximately 56% of its outstanding and issued shares rather than the authorized as noted on its June 21st Press Release caught investors off guard today with its after hours press release. The PR states “Unity Management Group Inc. is pleased to announce that its Board has agreed to retire and eliminate 127,036,820 from its issued and outstanding shares. These shares have been retired immediately, and are effective as of this release. The new structure is 240,000,000 authorized shares, and 100,000,000 issued and outstanding, with 43,439,000 in the float.
This announcement comes at a peculiar time when a press release is anticipated any day announcing the company’s completion of its acquisition of MCC Legacy, which is rumored to bring 2 million dollars in revenue to the company. Per its website, MCC is the leader in instrumentation, data acquisition systems, high-speed production tablet press replication and tablet press control systems for the pharmaceutical industry, having earned its reputation for technical excellence, quality service and client satisfaction. It was established in 1985 to serve companies that required outside help in technical programming. In 1986, Warner-Lambert commissioned MCC to create the first PC-based Tablet Press monitor in history. Today, MCC is an industry recognized expert in precision instrumentation, specializing in solid dosage form equipment.
At such a key time in the company’s existence, Unity Management has immediately retired 56% of its outstanding and issued shares which, all else being equal, should positively impact the company’s dwindling price per share. Unity Management Vice President Michael Oliver, who I have had the please of communicating with on a few occasions, noted in today’s press release that “After further reviews it makes more sense to lower the issued and outstanding, than the authorized, and puts less shares into the market, increases the market cap, which is better for the investors and shareholders".
The anticipation grows as the days close in on the acquisition completion that brings about a brand new path for Unity Management Group as it has embarked on a new mission this year with its sole focus on healthcare. This anticipation should culminate in the next few days and may even have been hinted at in today’s press release with the statement “The company will be holding its first live investor conference via telephone within the next week. The call in info will be posted on our next company press release.” Exactly what else will be mentioned in this press release? Nonetheless, I will certainly be participating in the investor conference and have high hopes of watching this small penny stock company go against all odds and typical penny stock perceptions and complete this acquisition and rapidly become the legitimate company that it appears to be becoming rapidly.
Disclosure: Long
Themes: Healthcare, Pharmaceutical, Legitimate, MCC Legacy, Metropolitan Computing Corporation, Stock buyback
Unity Management Group, Inc. Reduces Their Issued and Outstanding by 56%
MIAMI, FL, Oct 05, 2010 (MARKETWIRE via COMTEX) -- Unity Management Group, Inc. (PINKSHEETS: UYMG), a Health Resource Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies.
Unity Management Group Inc. is pleased to announce that its Board has agreed to retire and eliminate 127,036,820 from its issued and outstanding shares. These shares have been retired immediately, and are effective as of this release. The new structure is 240,000,000 authorized shares, and 100,000,000 issued and outstanding, with 43,439,000 in the float.
As previously announced the Board of Directors had agreed to the reduction of the authorized, but in light of the Letter Of Intent, and the completion of the due diligence of MCC/Legacy, the Company has decided that shareholder appreciation, and value would be better achieved through reduction of the issued and outstanding.
"After further reviews it makes more sense to lower the issued and outstanding, than the authorized, and puts less shares into the market, increases the market cap, which is better for the investors and shareholders," said Michael Oliver, Vice President.
The company will be holding its first live investor conference via telephone within the next week. The call in info will be posted on our next company press release. For more information please go to our website which can be found at www.unitymanagementgroup.com
Share structure:
240,000,000 million authorized
100,000,000 million issued and outstanding
43,439,460 million float
http://www.otcmarkets.com/stock/UYMG/company-info
http://nvsos.gov/sosentitysearch/CorpDetails.aspx?lx8nvq=njNiyrVP1Xicp2yrl4C0zg%253d%253d&nt7=0
Contact Guardian Registrar and Transfer Transfer Agent 7951 SW 6th Street Suite 216 Plantation, FL, 33324 954-915-0105
http://www.guardian-transfer.com/
Unity Management Group, a health resource company, will continue to provide innovative physician practice management services that offer high value and significant return on investment for physicians practices and hospitals through its three subsidiary companies: United Healthcare Solutions Inc., Unity Technologies Inc., and United Business Services Inc.
The first subsidiary, Unity Business Services, is a full service management company offering solutions in practice management, billing, staffing, contracting, licensing, credentialing, and accounting. Unity Business Services also offers assistance in HIPPA compliance, marketing, and unique solutions for practice start-ups and new practices.
Unity Technologies Inc. is a complete software solutions company offering billing, electronic medical records, and electronic health records for physicians' offices and hospitals.
United Healthcare Solutions, a national company based in Nevada, is a healthcare company will be providing medical, vision and dental discount plans, as well as PPO and HMO networks.
The combination of these three subsidies provides unprecedented access to skilled leadership, managed care expertise, information systems, and economies of scale. Alex Berkovich, President of United Management Group, stated, "Through this merger, we are in a unique position to address the rapidly changing needs of the medical community. Business expertise is critical to the success of today's physician offices and hospitals and we expect unpatrolled growth in the near future."
Unity Management Group Locations:
15325 N.W. 60th Avenue 1348 East Hillsboro Blvd.
Suite #101 Deerfield Beach, Florida 33441
Miami Lakes, Florida 33014
Contact: Unity Management Group,
Inc.
For more information, please visit our website at (www.unitymanagementgroup.com) or contact our office at 954-531-0387.
Certain information discussed in this press release may constitute forward-looking statements within the Private Securities Litigation Reform Act of 1995 and the federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions at the time made, it can give no assurance that its expectations will be achieved. Readers are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are inherently subject to unpredictable and unanticipated risks, trends and uncertainties such as the Company's inability to accurately forecast its operating results; the Company's potential inability to achieve profitability or generate positive cash flow; the availability of financing; and other risks associated with the Company's business. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events.
Contact:
Unity Management Group, Inc.
954-531-0387
SOURCE: Unity Management Group, Inc.
Copyright 2010 Marketwire, Inc., All rights reserved.
Thanks! Momo or catalyst?? What kind of time frame? You the man!! :)
Last week, Sanofi-Aventis (SNY) confirmed that it is on the prowl for diabetes partnerships. Bloomberg reported statements made by Riccardo Perfetti, the Senior Medical Director for Sanofi-Aventis’ diabetes unit, that Sanofi-Aventis may unveil “at least another couple critical partnerships” in diabetes in the months to come. Most interesting to me was a quote from stating that they:
“…may consider candidates for a successor to its best-selling product, the long-acting insulin Lantus, and for a new, fast-acting insulin”.
Given my recent interest in fast acting insulins up for approval soon, I spent some time considering this statement: Who would Sanofi-Aventis most likely be after?
I came up with three novel fast-acting insulin delivery systems which could be up for potential partnership: Mannkind’s (MNKD) Afrezza, Biodel’s (BIOD) Linjeta, and Halozyme’s (HALO) rHuPH20 insulin.
These three candidates are represent unique approaches to insulin delivery, and are all strong candidates to fill the needs which remain in the fast-acting insulin market. As an investor in this arena, I clearly would like to know which one is the most likely one up for partnership with SNY. In order to make a prediction, investors need to consider what needs these candidates could fill for SNY. To make this assessment, investors need to have some background about the existing fast acting insulin market, and the “next generation” players who are also seeking partnership. So first, some background:
Types of existing fast acting insulins:
The existing fast acting insulins all work on the same principle: The insulin is changed by altering its structure (substituting amino acids) so that it does not form hexamers. Native insulin is found in the hexameric state, which decreases its absorption rate when injected. Herein lies the problem: diabetics trying to time their insulin dose to control blood sugar find that it takes too long for regular insulin to enter the blood stream, causing blood sugar spikes (hypoglycemia); and due to its slow absorption remains in the blood stream too long causing dangerous blood sugar dips (hypoglycemia). Thus, the most critical factor for insulins are their pharmacokinetic profile; how quickly they enter and remain in the bloodstream.
The fast-acting analogues of insulin are altered to have charge repulsion at key locations on the molecule, which prevents the formation of insulin hexamers, and decreases the time it takes for them to enter the blood stream.
For the scientists, Insulin Aspart (Novolog) is regular insulin which has been mutated so that the amino acid proline on the beta-chain of insulin (B28), is substituted with an aspartic acid residue. Insulin lispro (Humalog) is made by switching positions B28 (Lys) and B29 (Pro) on the insulin beta -chain. Insulin glulisine (Apidra) is made by replacing the amino acid asparagine in the beta chain at position B3 with lysine and the lysine in position B29 with glutamic acid.
For the layman, all of these three modified insulins work in very similar ways: 1-2 mutations at critical sites in the insulin molecule prevent hexamers from forming, and the insulin is absorbed quicker.
Due to the similar nature of these insulins, all three of these fast acting insulins have nearly identical pharmacokinetic profiles (insulin lispro vs insulin glulisine shown below). These fact acting insulins distinguish themselves from standard recombinant human insulin (RHI), but not significantly apart from each other.
The major fast acting insulin players:
Of the three main insulin producers, Eli Lilly (LLY), Sanof- Aventis (SNY) and Novo Norodisk (NVO): Novo Nordisk has been involved in the diabetes market since insulin was first developed in the 1920s. Novo Nordisk sales of fast-acting insulin Novolog (insulin aspart) is the longest-established and highest-selling product in the fast acting insulin market. Eli Lilly is the second largest competitor with its fast-acting insulin product Humulog (insulin lispro). Both of these companies are stiff competition for Sanofi-Aventis, of the three the newest comer to the insulin market with Apidra (insulin glulisine). Sanofi has taken the lead of the long-acting insulin analog market with its blockbuster product, once-daily Lantus (insulin glargine), but Apidra sales pale in comparison to Novalog and Humalog.
Sanofi-Aventis’s position in the insulin market:
SNY’s global Lantus sales are projected to grow to an astounding $6 billion by 2014 when the patent expires, but SNY is struggling to compete in the fast-acting insulin market with Apidra due to its competition. Apidra wasn’t launched in the US until 2009, so sales have been minor compared to the competitors. However, Apidra was launched in the EU in 2005 and sales in 2009 were about $300 million. Compared to Novolog sales of $900 million and Humalog sales of $750 million in 2009, Apidra is likely to only have a minor share of the US fast acting insulin market. However, the US patent for Novalog expires next year, and the US patent for Humalog expires in 2014. Given that there is no fundamental or clinical basis for differentiating these three fast acting insulins (as described above), continued market pressure from the brand name and future generic forms of these drugs are likely to put sustained pressure on Apidra sales, even though Apidra has US patent protection until 2018. In consideration of these factors, and a loss of Lantus patent protection in 2014, Sanofi-Aventis is logically looking for a way to differentiate itself from the other fast acting insulins; as well as find a product that can replace Lantus sales by 2014.
This is the clear basis for the statement that they “may consider candidates for a successor to its best-selling product, the long-acting insulin Lantus, and for a new, fast-acting insulin”. Given the competitive state of market, the equivalent nature of the three fast acting insulins available, the time frame in which these players lose market exclusivity, and Sanofi’s position in this market, it makes perfect sense that Sanofi is looking for a new fast-acting insulin partnership and a solution to protect Lantus.
The “next generation” insulins
Novel insulins, like Mannkind’s Afrezza, Halozyme’s rHuPH20 insulin, and Biodel’s Linjeta have the same goal of rapid control of glucose, but take a vastly different approach than Apidra, Humalog, or Novalog. As well, these three companies all take vastly different approaches from eachother. Afrezza’s approach is to utilize chemically modified insulin which remains as monomers (Technosphere) and the dense lung vasculature to absorb inhaled insulin quickly. Linjeta’s approach is also to use chemically modified insulin to prevent insulin hexamers and thus fast absorption by injection. Halozyme’s approach is to change the tissue at the site of injection to allow faster absorption. All these approaches work better than the existing insulins Apidra, Novolog, and Humalog as demonstrated below:
When compared directly to insulin lispro, Afrezza is absorbed very quickly into the blood, reaching peak plasma concentrations in 15-20 minutes; compared to 50-60 minutes for insulin lispro.
When compared directly to insulin lispro, Linjeta is also absorbed very quickly into the blood, reaching peak plasma concentrations by 25-30 minutes; compared to 50-60 minutes for insulin lispro.
The concept behind Halozyme’s rHuPH20 insulin is different than both Afrezza and Linjeta. The concept behind Halozyme’s “Enhanze” technology is the use of an enzyme called hyalronidase that locally degrades body components under the skin to enable quicker absorption of a drug (like insulin) into the blood. The principle behind this is that the layer of tissue under skin is composed partly of hyalronic acid, a water-absorbing protein that gives tissues under the skin their “bounce”. Halozyme’s Hylenex hyalronidase degrades the hyalronic acid locally at the site of injection, disrupting tissue structure, and allowing absorption into neighboring capillaries quicker. Halozyme has gained approval for their Hylenex (rHuPH20) drug with co-administration with other drugs for certain pediatric uses.
In the case of this drug, there is still the problem of insulin forming hexamers, so a fast acting insulin such as Novolog, Humalog, or Apidra must still be used. However, when combined, there is quicker absorption of the insulin into the blood stream as shown below. This does not appear to be faster than Afrezza or Linjeta, but is certainly an improvement over insulin lispro.
Humalog, and Novolog have improved on their stand-alone fast acting insulin products by marketing mixes of fast-acting and regular insulin (Novolog 70/30, and Humalog 70/30). However, these mixes are only for diabetics who need insulin in between mealtime as well as at mealtime. The basal insulin in these products does not last as long as the long-lasting Lantus, and interim injections of basal insulin are often needed despite this mixture. Thus, there are two gaps to fill: First, better mealtime control of insulin that Afrezza, Linjeta offers, and potentially Halozyme’s rHuPH20 insulin can offer; and second an all-inclusive insulin that only requires use at mealtime and provides coverage between meals. Solving these problems are the “holy grail” of insulin, and any product brought to market which offers this clearly has a competitive advantage over all existing and future products.
Who will SNY choose to partner with?
None of these products are mutually exclusive; SNY inferred multiple partnerships and may chose one or all (or none) of these as partners, as each one has unique characteristics and thus SNY would have unique rationale for choosing one. However, because of these unique characteristics, we can weigh what may be the most likely partner for SNY given the current fast acting insulin environment.
Formulating the fast acting insulin with Halozyme’s rHuPH20 may in fact give added benefit to diabetics (improved glucose control, less hypoglycemia, weight loss) due to improve pharmacokinetics, but this remains to be proven. It is clear that Linjeta and Afrezza have distinct advantages over the current fast acting insulins; if Novolog, Humalog, and Apidra could improve their pharmacokinetic profile by using rHuPH20, they would be able to compete with them. Also, Halozyme’s formulation offers means for additional patents and market exclusivity extension for the fast acting insulins facing patent expiration relatively soon (Novolog, Humalog).
However, Halozyme has only completed phase II studies with insulin lispro. They have just begun their phase III studies, which could take a couple years, and if successful would put them up for FDA approval sometime in 2014. This would be too late for Novolog (2011); and right on time for Humalog (2014). The fact that they are using lispro insulin, and the timing needed to complete trials, positions them with a partnership with Eli Lilly to use with Humalog. The intended use and timing seems wrong for a HALO-SNY partnership and best for a HALO-LLY partnership.
In contrast, the timing for Mannkind’s Afrezza is excellent. Certainly Afrezza meets SNY’s desire for an improved fast acting insulin product. After several delays, Afrezza is up for approval again on December 29th of this year. This seems to fit the time frame for partnership SNY is seeking. However, Afrezza is a novel drug/device combination, which requires the 505(b)1 approval route and the combination drug/device is making gaining FDA approval more difficult ( this is the cause for repeated delays in its approval). If delayed again this December, it would still be up for approval again in early 2011, which seems to still fall inside of the time frame SNY may announce a partnership.
However, as I discussed in a previous article, inhaled insulin carries significant marketing acceptance, Inhaled insulin also may require risky post-labeling safety risks due to real or perceived potential pulmonary risks associated with inhaled insulin (black box warning) and post-marketing follow-up studies. In addition to this, a partnership with MNKD would have to be quite expensive to start to recoup the well over $1 billion development costs of Afrezza. Mannkind has maintained that Afrezza would be competitive in pricing to existing fast acting insulins, which makes profit margins lower and harder to justify and an expensive partnership with MNKD for a good return on investment. These are often stated reasons as to why Mannkind has not come forward with a partnership yet, and may also be reasons why SNY might be hesitant to partner Afrezza.
Yet, this is not reason alone to exclude a SNY-MNKD partnership. As well, a MNKD-NVO partnership seems just as likely given the urgency required for NVO to replace lost Novolog sales due to loss of marketing exclusivity in 2011; or similarly a LLY-MNKD partnership to replace Humalog (although neither company has stated they are seeking partners). But one major problem with Afrezza in relation to the strategy of such partnerships is that it does not fulfill the need to replace the Novalog 70/30 and Humalog 70/30 fast-acting/basal insulin combinations, as Afrezza is inhaled and basal insulin is injected. Thus, although Afrezza may improve fact-acting insulin, it cannot be used immediately to replace these products, nor to develop the “holy grail” combination of a singular fast-acting/long lasting insulin product.
However, Linjeta is perfectly positions to accomplish this. As I wrote in a previous article, the injectable insulin platform is one that is comfortable to drug companies (and insulin users), and seemingly provides the least amount of marketing risk. In addition to this, injectable insulins pose little pre-and-post marketing regulatory risk, as they have been used for decades. Biodel’s Linjeta stands out in this arena not only as a superior fast acting insulin over the existing marketed products, but is seeking approval under the 505(b)2 mechanism as a new formulation of an existing drug. Apart from the troublesome Indian data (discussed here), there are no clear risks for approval, and no perceived risked for marketing. Linjeta would easily fill the need for an improved fast-acting insulin to gain a decent market share in the face of Apidra’s existing competitors Novolog and Humalog; as well as the generic versions that will be on the market before Apidra loses market exclusivity.
It is easy to rationalize why SNY may favor an injectable insulin over Afrezza, as the marketing would be the same as Apidra but SNY could claim superiority over Novolog and Humalog. BIOD plans to market Linjeta in the U-100 (100 units insulin/ml) formulation in 10ml vials or 3ml injector pens- identical to the current Apidra products sold as U-100 formulation in 10ml vials or 3ml cartridges for use with an insulin pen marketed as Apidra SoloSTAR. This format is also available to Novolog and Humalog users, so it is easy to see how integration of an improved insulin into an existing use marketing space would be easy and successful. Thus, it seems more likely that SNY would choose this format (and thus Linjeta) over the inhaled insulin (Afrezza) format for partnership.
But there are more pieces to the puzzle that heavily sways bias towards SNY choosing BIOD as a partner over all others: Lantus. The long acting insulin Lantus fills a need not covered by fast acting insulins for diabetics who need insulin between meals as well as at mealtime. A considerable portion of Lantus sales also comes from its use in insulin pumps. However, with Lantus losing marketing exclusivity in 2014, SNY needs to keep its share of this market by introducing a new, superior product to the market. BIOD is currently testing the use of Linjeta in insulin pumps (trial NCT01067118), and would fill this need (if successful) by 2014 when Lantus comes off patent.
However, one of the key pieces of evidence, which makes me believe that BIOD would be the partner of choice for SNY, is the need for SNY to bring to market an improved long acting/ fast acting injectable combination mixture to outcompete all the others (the “holy grail”). As previously mentioned, NVO sells Novolog 70/30, and LLY sells Humalog 70/30; fast acting insulin/basal insulin mixtures for the purpose of providing glucose control at meals and between meals. However, SNY does not sell an Apidra/Lantus mixture because Lantus cannot be mixed with mixed with Apidra or any other fast acting insulin as the mixture causes Lantus to precipitate prior to injection and administration, and this makes it virtually impossible to administer a known and reliable dose.
Fortunately for SNY, someone has designed a unique product that was designed specifically to fill in this gap: Investors should note that Biodel has quietly gained US patent 11695562 pertaining the use of fast and long acting insulin mixtures for injection. The patent pertains specifically to the use of injectable mixture of glargine insulin (Lantus), and VIAject/Linjeta.
Linjeta (VIAject) is a unique fast-acting insulin due to its low pH formulation, which makes it compatible for direct mixture with Lantus. Although stand-alone Linjeta has been reformulated to a neutral pH for comfort, the phase III Linjeta trials were performed using the more acidic formulation. This appeared to be a boondoggle for BIOD, as the pH caused some discomfort at the injection site; but really appears to be a boon for BIOD as this formulation allows it to be combined directly with Lantus, as the patent demonstrates. Given that the pH of the Linjeta formulation can be changed for different uses, but Lantus cannot, this positions Linjeta as the perfect drug to be combined with Lantus for diabetics who need both short term blood sugar control at mealtime and long term insulin between meals (the “holy grail”). As well, Linjeta can be used separately as the to-be-marketed neutral pH formulation in injection pens at mealtime by diabetics who do not need long acting insulin between meals. However, Linjeta is the only product with the right chemistry that fulfills both of the needs SNY is looking to fill, and has already obtained the intellectual property specifically surrounding this.
BIOD has quietly developed an improved mixed insulin product compatible with Lantus, which would allow the “holy grail” combination fast-acting/long acting insulin to be created.
This product, if created, fills the current unmet need of fast/long acting insulin mixtures, and also fills the exact niche that SNY needs to corner the market.
This partnership alone would allow patent extension for Lantus past 2014 as the Lantus/Linjeta mixture (say it out loud- is this why they changed the name from VIAject to Linjeta?).
This partnership would also provide an improved fast-acting insulin that can compete with Novalog and Humalog sales, and their eventual generic counterparts as it provides superior benefits.
The quote made by the SNY spokesperson that they “may consider candidates for a successor to its best-selling product, the long-acting insulin Lantus, and for a new, fast-acting insulin” basically spells this out in plain words. In my opinion, this partnership makes too much sense to be discounted. The idea of this partnership is not just conjecture- the patent for the Lantus/Linjeta mixture is an obvious business strategy that clearly BIOD and presumably SNY have been considering for quite some time now.
Biodel, BIOD, due diligence. Rumors have been circulating the boards that Sanofi-Aventis, SNY, is looking for a partnership or buyout of a fast-acting insulin company. Have a look at Joe's article on Seeking Alpha:
http://seekingalpha.com/instablog/492120-joseph-krueger/96542-sanofi-aventis-is-on-the-prowl-for-the-holy-grail-of-insulin
Alexza Pharmceuticals, ALXA information:
Loxapine is currently FDA approved for use in reducing agitation in schitzophrenic patients. Its current applications utilize 5 mg, 10 mg, 25 mg, or 50 mg pills. In normal human volunteers, signs of sedation were seen within 20 to 30 minutes after administration, were most pronounced within 1½ to 3 hours, and lasted through 12 hours.
In Alexza's AZ-004 stacatto application, 5 to 10mg are administered.
This should help out the safety profile as opposed to the higher dose oral applications in which there is some concern, although the drug is approved and being used.
Read more: http://www.drugs.com/pro/loxapine.html#ixzz0scBPJB3e
Read more: http://www.drugs.com/pro/loxapine.html#ixzz0sc88s12C
•INTENDED INDICATION: Acute Treatment of Agitation associated with
Schizophrenia or Bipolar Disorder
•PATIENT POPULATION: 2.4 million schizophrenia patients and 5.7
million bipolar disorder patients in the United States; agitation is a
common and severe symptom.
•STATUS: Successfully completed two Phase 3 trials: a 344-patient
trial for schizophrenia and a 314-patient trial for bipolar disorder.
Both trials met primary and secondary endpoints. The company submitted
an NDA in December 2009.
AZ-004 trials http://clinicaltrials.gov/ct2/show/NCT00721955
PDUFA Date is October 11th.
Analyst estimates 6.50
Also of note is that it has already had a $18 million offering to cover expenses and no FDA panel between now and the October PDUFA which should give us a nice, steady trend upward depending on market conditions. So, no panel and no dilution concerns.. I like!!
I'm hoping so!! I see UYMG going well above and beyond that by December! Can we add another "0" to that 100?? Additionally, I opened a position today in ALXA for its October 11th PDUFA. I'm maintaining my long position in UYMG but will likely flip some to move into ALXA and BIOD by the end of the week.
I love both companies Chemist! I think BIOD and UYMG can see 100% gainers from current levels before Nov :)
Unity Management Group (Pink Sheets UYMG) is bringing MCC Legacy back into the investment world’s spotlight with its July 29th press release announcing its intention to acquire it http://www.marketwire.com/press-release/Unity-Management-Group-Inc-Enters-Into-Letter-Intent-Acquire-Metropolitan-Computing-1297373.htm. MCC Legacy had been owned by Bedminster National Corporation as of July 3, 2007 and was then apparently taken over by Dutchess Private Equities Fund, Ltd per agreement of January 14, 2008 via http://msnmoney.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?ID=5660621&SessionID=GKeKWZn2t35_P49.
MCC is a leader in instrumentation, data acquisition systems, high-speed production tablet press replication and tablet press control systems for the pharmaceutical industry, and has earned a reputation for technical excellence, quality service and client satisfaction. It was established in 1985 to serve companies that required outside help in technical programming. In 1986, Warner-Lambert commissioned MCC to create the first PC-based Tablet Press monitor. Today, MCC is an industry recognized expert in precision instrumentation and specializes in solid dosage form equipment. Much more can be viewed in the form of presentations and videos on its website at http://www.mcc-online.com/. The website itself, though relatively simple, lets one see the types of products and intellectual property that MCC Legacy possesses.
Unity Management’s upcoming finalization of the MCC purchase not only will provide it with approximately 2 million dollars in revenue, but it will also complement its existing three healthcare divisions. MCC Legacy’s customers will now become Unity Management’s customers and will greatly expand its clientele and exposure in the pharmaceutical and healthcare world. Per Unity Management’s press release announcing its letter of intention to acquire MCC, the following pharmaceutical companies were noted as MCC’s clientele: Pfizer, Merck, Bristol Meyers, Amgen, Bend Research, Purdue Pharma, Hoffman LaRoche, ISP, Boeringer Ingelheim , Exelixix, Watson Labs, Aqualon, Astra Zeneca, Schering-Ploughs, Novartis, Abbot Labs, JCMCO, Mendel company, Cobalt Pharma, Medelpharm, Patheon, Sanofi-Aventis, Barr Labs, Covidien Pharma, Forest labs, Azopharma, and Genzymebecome.
Although MCC Legacy has been out of the investors’ eyes due to its ownership by a private entity for the last couple of years, it apparently has not been out of the pharmaceutical world’s eyes as seen from the afore-mentioned list. It has been hard at work obtaining patents, presenting its products and intellectual products to the pharmaceutical industry and likely gaining more business. If one performs a search on the web for MCC Legacy Products he finds a myriad of presentations and PDF files. Following are some links to some very impressive documents and presentations that MCC Legacy either composed or had a large part in developing:
http://pharmacyebooks.com/2009/03/pharmaceutical-process-scale-up-drugs-and-the-pharmaceutical-sciences.html
http://www.faqs.org/patents/app/20090115090
http://www.freepatentsonline.com/7553436.html
http://www.boliven.com/patent/US6482338
http://www.slideshare.net/elfoxy99/tableting-scale-up-presentation
Unity Management will be closing on this acquisition any day now and should release a press release announcing such and other details. Unity recently became updated to “current status” on pink sheets, so we should see MCC Legacy’s financials if not with the press release announcing the completion of the acquisition then at least with the 3Q or 4Q 2010 financials. MCC Legacy will not only re-enter the investment world again as a publically held entity, but it will also be transparent in its financial reporting.
Investors will be closely watching Unity Management Group closely over the next few weeks as it grows and takes a solid foothold in the healthcare industry. Headlines from 2010 alone tell the story of Unity’s growth from acquisitions, stock retirement, stock buybacks, financial transparency, additions of key personnel and many other items to come. Unity Management Group, like MCC Legacy, is getting the attention of the investment world. It has transformed itself in one year to a key healthcare entity and will likely continue its torrid growth pace impressing not only investors but also the healthcare and pharmaceutical industries.
Biodel, BIOD, is awaiting its PDUFA date in October. There will be no FDA panel event leading up to that date. Also buzzing through rumor mills is possible buyout or partnership due to its new member of its board of directors. Have a look at his bio:
"announced today the appointment of Arthur Urciuoli to the company's board of directors. Mr. Urciuoli is chairman of ArcherGroup, a private investment and consulting services firm, and was recently elected to the board of the newly-formed Kroll Bond Rating Agency. He is a retired chairman of Merrill Lynch International and former director of Kroll, Inc. He spent 30 years at Merrill Lynch & Company where he held a variety of senior leadership positions, including chairman and chief executive of Merrill Lynch Business Financial Services and director of Merrill Lynch Private Banking, and was a syndicated columnist and frequent guest speaker on investing and business management."
WOW!!
Hello and welcome aboard our board! Please note that we welcome and encourage all due diligence for undervalued healthcare and biotech stocks. However, please also realize that valid due diligence may be positive or negative relative to your views or current position in a stock.
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